Which Medical Device | News

Impact sports reduce the longevity of hip replacements

Thu, 17 May 2012 10:14:10 GMT

Returning to impact sports such as jogging, soccer or martial arts is a goal for some patients after total hip arthroplasty, but the effect of this on longevity of the implant is poorly understood. In a review of 70 patients who had undergone total hip arthroplasty published in Clinical Orthopaedics this month, Ollivier et al have demonstrated higher hip scores, but also higher linear wear and a higher revision rate in patients undertaking impact sports compared to controls. At 15 years, survivorship was 80% (74% to 86%) in the high impact group, and 93.5% (88.2% to 97.6%) in the controls.

Patients received the Symbios cementless HA coated stem, a cementless hydroxyapatite coated acetabular component with conventional polyethylene and a 28mm ceramic head.

Reference

Ollivier M, Frey S, Parratte S, Flecher X, Argenson JN. Does Impact Sport Activity Influence Total Hip Arthroplasty Durability? Clin Orthop Relat Res. 2012 Apr 25. [Epub ahead of print]

Ellipse ICD receives FDA approval

Wed, 16 May 2012 13:59:32 GMT

The Ellipse ICD, manufactured by St. Jude Medical has recently received approval from the U.S. Food and Drug Administration (FDA). The new implantable cardioverter defibrillator is the smallest high-voltage ICD available in the industry and has already been approved by European regulators.

Find more information on the Ellipse ICD here.

Wii-hab as good as physiotherapy after cruciate ligament reconstruction

Mon, 14 May 2012 09:52:50 GMT

In a prospective randomised double-blind study, researchers from the Hacettepe University, Ankara have demonstrated that using wii-sports after anterior cruciate ligament reconstruction is as good as conventional rehabilitation. The team randomised thirty volunteer patients to 12 week programmes comprising standard rehabilitation or Wii-hab including the balance board and Wii Sports and Sports Pro games. Participants were indistinguishable on measures of knee strength, balance and functional squat tests at the first, 8th and 12th weeks postoperatively.

Reference

Baltaci G, Harput G, Haksever B, Ulusoy B, Ozer H. Comparison between Nintendo Wii Fit and conventional rehabilitation on functional performance outcomes after hamstring anterior cruciate ligament reconstruction: prospective, randomized, controlled, double-blind clinical trial. Knee Surg Sports Traumatol Arthrosc. 2012 Apr 29. [Epub ahead of print]

Access the full summary of this study here.

View a range of devices designed for use in knee procedures here.

Study demonstrates lower wear rates in highly cross-linked polyethylene bearings in hip replacement in under 65s

Fri, 11 May 2012 15:15:47 GMT

Adding to the debate about bearing surfaces, a team from St Michael’s Hospital in Toronto studied 102 hip replacements in 91 patients randomised to receive either a cobalt-chrome on ultra-high molecular weight polyethylene (UHMWPE), cobalt chrome on highly cross-linked polyethylene (HXLPE), or a ceramic-on-ceramic bearing. All patients received a Smith and Nephew Synergy uncemented stem and a Reflection uncemented acetabular component. Bearings were 28mm cobalt-chrome heads with UHMWPE, HXLPE or ceramic-on-ceramic. 87 patients were available for five year review.

The team found no differences in outcome scores or failure rates, but did find a significant difference in mean polyethylene wear rates; 0.151 mm/year for UHMWPE compared with 0.059mm/year for HXLPE. The ceramic-on-ceramic bearing wear was less at 0.0067mm/year, but 3 of 34 patients had squeaking of the bearing.

For more information on this study, please refer to the Journal of Bone and Joint Surgery (British Volume) article by VS Nikolaou et al here.

Study finds no evidence that hip resurfacing leads to better outcomes than total hip arthroplasty at one year

Sat, 05 May 2012 15:29:46 GMT

The BMJ continues to demonstrate its interest in metal on metal hip replacements by publishing a study from Costa et al of Warwick University (1). 126 patients thought suitable for hip resurfacing were randomised either to hip resurfacing or total hip arthroplasty. Outcomes at one year measured by Harris hip score and Oxford hip score were not significantly different between the groups. However, this was a pragmatic study comprising a number of different implants and surgeons and the confidence intervals for this result were wide. It has become clear that not all hip resurfacing devices are the same.

Other authors have noticed a greater improvement in quality of life scores (SF36) and WOMAC scores in patients who have had resurfacing compared to total hip replacement (2,3).

(1) Costa ML, Achten J, Parsons NR, Edlin RP, Foguet P, Prakash U, Griffin DR; Young Adult Hip Arthroplasty team. Total hip arthroplasty versus resurfacing arthroplasty in the treatment of patients with arthritis of the hip joint: single centre, parallel group, assessor blinded, randomised controlled trial. BMJ. 2012 Apr 19;344:e2147. doi: 10.1136/bmj.e2147.

(2) The Alberta Hip Improvement Project. Functional Outcomes for 2 Years Comparing Hip Resurfacing and Total Hip Arthroplasty. J Arthroplasty. 2012 May;27(5):750-757.e2. Epub 2012 Jan 28.

(3) Lingard EA, Muthumayandi K, Holland JP. Comparison of patient-reported outcomes between hip resurfacing and total hip replacement. J Bone Joint Surg Br. 2009 Dec;91(12):1550-4.

CABG more effective than PCI in treatment of non-emergency multi-vessel coronary disease in older patients

Thu, 03 May 2012 16:26:06 GMT

A collaborative observational study undertaken by the American College of Cardiology Foundation (ACCF) and the Society of Thoracic Surgeons (STS) compares the effectiveness of percutaneous coronary intervention (PCI) and coronary-artery bypass grafting (CABG) in the treatment of older patients with two- or three-vessel coronary artery disease not requiring emergency treatment.

The study, which links data from the ACCF National Cardiovascular Data Registry and the STS Adult Cardiac Surgery Database, to claims data from the Centers for Medicare and Medicaid Services, compares long-term survival rates in 86,244 patients aged 65 or over who have undergone CABG surgery and 103,549 patients receiving PCI treatment. While there is no reported significant difference in adjusted mortality rates between the two groups at the 1 year follow-up mark, at 4 years patients treated with CABG reveal lower rates of mortality compared to those who have undergone PCI (16.4% vs. 20.8%; risk ratio, 0.79; 95% CI, 0.76 to 0.82). Similar findings were noted with several different methods of analysis and in multiple patient subgroups.

To access the full New England Journal of Medicine summary of this study, click here.

Compare a range of devices used in coronary intervention procedures here.

Smoking linked to joint replacement failure

Tue, 01 May 2012 12:58:23 GMT

Two new studies presented at the American Academy of Orthopaedic Surgeons (AAOS) 2012 Annual Meeting reveal the damaging effects of smoking on total joint replacement.

The first, an analysis of 621 patients undergoing total knee replacement (TKR) procedures, assessed clinical outcomes including pain, function and range of motion, in smokers and non-smokers. Of the group of smokers, knee replacement failure rate was 10 times higher than in those classed as non-smokers. The rate of additional medical complications including DVT, blood clots, anaemia requiring treatment, cardiac problems and acute renal failure was also revealed to be 'significantly higher' in smokers.

The second study investigated the effects of smoking on patients undergoing acetabulum reconstruction surgery using ultra-porous metal. Generally, these newer materials have shown a tendency to lead to fewer hip replacement failures and higher survival rates than implants made from standard porous metals. In this study of 533 hip replacements (159 primary and 374 revision surgeries) a failure rate of 9.1% was recorded in smokers, compared to the 3.4 % observed in non-smokers.

More information on these studies and the related AAOS Smoking Cessation Forum can be found here.

View devices used in knee replacement procedures here.

View a range of acetabular components here.

Lancet study reveals lower rates of stent thrombosis with cobalt-chromium everolimus eluting stents

Sun, 29 Apr 2012 13:10:04 GMT

A network meta-analysis of randomised controlled trials comparing different drug-eluting stents, or drug-eluting with bare-metal stents, has revealed that cobalt-chromium everolimus eluting stents (CoCr-EES) deliver the lowest rate of stent thrombosis within two years of implantation.

The 49 trial sample analysis includes results from more than 50,000 patients and revealed a number of findings. The incidence of 1-year definite stent thrombosis was significantly lower with CoCr-EES than with bare-metal stents (odds ratio [OR] 0·23, 95% CI 0·13—0·41). The significant difference between these stent classes was evident from as early as 30 days, and also in the 31 day - 1 year period. CoCr-EES were also linked to significantly lower rates of 1-year definite stent thrombosis When compared with paclitaxel-eluting stents, permanent polymer-based sirolimus-eluting stents, phosphorylcholine-based zotarolimus-eluting stents, and Resolute zotarolimus-eluting stents.

No other drug-eluting stent had lower definite thrombosis rates compared with bare-metal stents at 2-year follow-up.

The full summary of this study can be found here.

Compare Which Medical Device listings for drug eluting stents here.

Stryker Mitch/Accolade total hip replacement should no longer be used

Sun, 22 Apr 2012 16:56:31 GMT

Ongoing concerns about metal-on-metal hip bearings have continued with the issue of a UK MHRA alert about the combination of the Stryker Mitch large metal-on-metal bearing with the Accolade stem. Analysis of the England and Wales National Joint Registry data has demonstrated a revision rate of 8.8% at 4 years for all Mitch/femoral stem combinations which is higher than the NICE benchmark. Interestingly, revision rates with the uncemented Accolade stem were substantially worse than with the cemented Exeter stem (4 year revision rate 10.7% compared with 3.7%).

The Mitch resurfacing has a lower revision rate of 3.1% at 4 years, which is in line with NICE guidance.

The Mitch bearing is manufactured by Finsbury Orthopaedics, which was acquired by DePuy in 2009.

MHRA alert: air or gas-pressurised spray devices for application of sprayable fibrin sealants in intra-operative haemostasis

Wed, 11 Apr 2012 17:12:40 GMT

The MHRA has issued a medical device alert for air- and gas-pressurised spray devices used in the application of sprayable fibrin sealants for intra-operative haemostasis.

The MHRA warns of a risk of life-threatening or fatal embolism occurring in patients during, or immediately after, application of fibrin sealants via air- or gas-pressurised spray devices. According to the MHRA, those adverse advents reported seem to be linked to use of the spray device in conditions not endorsed by the manufacturer: either at a greater pressure setting, or closer to the tissue surface, than recommended.

Devices currently available in the UK which may be affected by this issue:

Evicel Fibrin Sealant (human) and spray device (Omrix Pharmaceuticals)
Quixil Fibrin Sealant (human) and spray device (Omrix Pharmaceuticals)
Tisseel Lyo Fibrin Sealant and Tisseel ready to use Solutions for Sealant (Baxter Healthcare) when used with EasySpray application devices (Baxter Healthcare)

Read the official MHRA alert including recommended actions for medical practitioners using this device here.

View more information on tissue products used with fibrin sealants here.

Lancet study reveals high failure rate in stemmed metal-on-metal hip replacements

Tue, 03 Apr 2012 09:54:46 GMT

A new Lancet study provides analysis of hip replacement failure rates in relation to prosthesis head size, using data collected from National Joint Registry of England and Wales records of primary hip replacements undertaken between 2003 and 2011. The study, based on an analysis of 402 051 primary hip replacements (31 171 of which stemmed metal-on-metal) concludes that stemmed metal-on-metal THRs fail at high rates, with larger heads failing earlier.

Click here to access the complete abstract of this Lancet study (please note, a Lancet subscription or one-off payment is required in order to access the full article).

Related news and editorials

New MHRA alert for metal-on-metal hip replacements (28th February 2012)

Editorial: navigating the narrow straits of device regulation (7th February 2012)

NICE publishes guidance on use of the PleurX Catheter Drainage System for patients with treatment-resistant recurrent malignant ascites

Wed, 28 Mar 2012 14:28:29 GMT

The National Institute for Health and Clinical Excellence (NICE) has recently published final guidance supporting use of the PleurX catheter system from CareFusion. The report suggests that the catheter drainage system could help improve patients’ quality of life, reduce complications and result in significant financial savings for the NHS.

The assessment, carried out through NICE’s Medical Technology Evaluation Program, concluded that the PleurX system should be considered for use in all patients with treatment-resistant recurrent malignant ascites.

The PleurX catheter drainage system is inserted into a patient’s abdominal space and enables fluid build-up to drain out into a vacuum bottle. This process can be carried out by the patient, in their own home, potentially eliminating as many as 15 days per month of additional hospital-based treatment for those requiring such fluid drainage procedures.

Access a PDF of the NICE guidance document 'PleurX peritoneal catheter drainage system for vacuum assisted drainage of treatment-resistant recurrent malignant ascites' here.

Find out more about the PleurX catheter drainage system from CareFusion here.

Endovascular Repair Effective for Inflammatory AAA

Thu, 01 Mar 2012 14:11:49 GMT

A study, reported in Cardiology News (28/02/2012) suggests that patients with inflammatory abdominal aortic aneurysms (AAAs) can be treated safely and effectively by endovascular aneurysm repair (EVAR), though those with significant hydronephrosis may have worse outcomes.

The retrospective study was conducted between 1999 and 2011 and included 69 patients who underwent either endovascular repair (10 patients) or open surgical repair (59 patients) at the surgeon's discretion.

Dr William M stone, speaking at the annual meeting of the Southern Association for Vascular Surgery, reported that although previous case series and meta-analyses had reported mixed results in cases with EVAR procedures, the current study suggests that EVAR may be considered appropriate management for inflammatory AAAs.

Learn more about the history of EVAR and current devices in this editorial, by Dr R Allison and Dr J Rose.

The full text of the Cardiology News report on the above study can be accessed here.

New MHRA alert for metal-on-metal hip replacements

Tue, 28 Feb 2012 16:10:04 GMT

Today (28/02/2012) the Medicines and Healthcare products Regulatory Agency (MHRA) issued fresh advice to clinicians, following earlier fears for the safety of metal-on-metal (MoM) hip replacements. According to the MHRA, patients with a particular type of metal-on-metal hip replacement should be monitored annually for the life of the hip replacement, and not just for the minimum 5 year post-operative period originally stated in April 2010.

The updated advice features in a new MHRA Medical Device Alert issued to clinicians managing patients with metal-on-metal hip implants, and aims to minimise the risk of such individuals requiring further surgery to correct complications.

Read the full text of the MHRA press release here or link directly to the medical device alert PDF here.

FDA officer advises on live case demonstrations of devices

Fri, 24 Feb 2012 13:18:33 GMT

Dr Andrew Farb, a medical officer at the U.S. Food and Drug Administration (FDA) has advised clinicians on live case demonstrations of devices.

A study in the Journal of the American College of Cardiology: Cardiovascular Interventions suggests that broadcasting heart procedures live to doctors at medical meetings may not present a risk to the patient on the table. Doctors at Rambam Medical Center in Haifa, Israel reviewed 101 patients treated during live transmissions from a single center in 15 invasive-cardiology conferences between 1998 and 2010. The study found that procedural and 30-day clinical outcomes were similar to those found in daily practice and to those that have been reported in the contemporary published data, and concludes that these results suggest that broadcasting live case demonstrations in selected patients from selected centers may be safe.

Such demonstrations must first be approved by the FDA. In an interview with Reuters Health, Dr Andrew Farb, who co-wrote an editorial published with the findings said the main goal of these demonstrations is to increase awareness of a clinical trial, and possibly get more doctors to enroll patients in it. This, he stated, is part of the FDA's "mission" to help get clinical trials done in a timely manner and get effective treatments into practice.

Dr Farb also noted that the demonstrations must clearly state that the procedure involves an "investigational device," and the operators cannot try to commercially promote the device.

The full article from the Journal of the American College of Cardiology can be found here.

Read the Reuters Health interview with Dr Andrew Farb here.

Field safety notice issued for Anaconda and Anaconda ONE-LOK stent graft

Thu, 23 Feb 2012 16:32:20 GMT

The MHRA has issued a field safety notice for the Anaconda and Anaconda ONE-LOK stent graft from Vascutek.

The manufacturer states that it has identified from a small number of field reports (less than 0.05% of the total number of devices distributed) that under exceptional circumstances an additional procedure may be required to remove the bifurcate body delivery system. No product recall is required.

Read the full letter from Vascutek here.

Find out more about the Anaconda AAA stent graft system here.

MHRA issue field safety notice for Biosense Webster CARTO 3 System

Wed, 22 Feb 2012 11:15:13 GMT

The MHRA has issued a field safety notice for the CARTO 3 System which may be susceptible to ablation radio frequency interference through certain interconnected cable configurations. The issue can manifest itself as a jumping or disappearing catheter icon or error messages during ablation.

Biosense Webster have issued a statement identifying the root cause of the issue as a newly introduced Patient Interface Unit (PIU) Backplane card, which is more sensitive to radio frequency interference. Biosense Webster is contacting institutions supplied with one of the affected CART 3 Systems with the new backplane card and will provide alternative equipment.

Read the full letter from Biosense Webster here.

Find out more about the CARTO 3 System here.

Edwards Lifesciences announce promising new transcatheter patient data

Thu, 02 Feb 2012 10:49:21 GMT

Patient data from a recent clinical trial shows reduced mortality rates in high-risk surgical patients with severe aortic stenosis. The patients were treated with transapical transcatheter transapical transcatheter aortic valve replacement (TAVR) during the continued access period of Cohort A of The PARTNER Trial,

The findings on the Edwards SAPIEN transcatheter heart valve were announced this week, and Michael A. Mussallem, Edwards Lifesciences' chairman and CEO said "It is encouraging that, in this much larger group of patients treated with transapical valve replacement, investigators observed a trend toward patients feeling better faster and having improved outcomes. We believe this more recent experience adds strong new support to the transapical procedure as an important option for patients who are at high-risk for surgery."

Read the full press release from Edwards Lifesciences here.

Find out more about the SAPIEN Transcatheter Heart Valve here.

MHRA issues statement on metal-on-metal hip implants

Mon, 30 Jan 2012 14:35:55 GMT

The MHRA have issued a statement on DePuy's metal-on-metal hip implants, while the Telegraph newspaper reports concerns that the devices could be more dangerous than previously thought.

On Monday 30th January 2012, an MHRA spokesman said, "On the evidence currently available the majority of patients implanted with metal-on-metal hip replacements are at low risk of developing any serious problems. We are continuing to closely monitor all evidence. This needs more analysis before any conclusions can be drawn and further advice given.

"We have already taken prompt action to investigate safety concerns and have provided advice on patient management to relevant healthcare professionals. If patients have any questions they should speak to their orthopaedic surgeon."

This statement comes two days after the Telegraph reported on their own investgation into these devices, which found that they were more dangerous than previously thought. The article, published on Saturday 28th January 2012, stated that there were concerns that "the fragments could put the nervous system, heart and lungs at risk of being slowly poisoned". The article also claims that advisers to the MHRA have decided that further advice should be issued due to concerns that the devices could cause “systemic toxicity” in the body.

Read the full statement from the MHRA here.

Read the article in the Telegraph here.

Read our roundup of metal-on-metal hip resurfacings here.

Medtronic completes enrollment of extreme risk patient group in CoreValve trial

Wed, 25 Jan 2012 14:29:40 GMT

Medtronic has announced the completion of the company's patient enrollment in the extreme risk study in its CoreValve U.S. Trial. The company also received FDA approval for an extended investigation (under the FDA’s Continued Access Policy) to continue enrolling extreme risk patients under a Continued Access Study protocol.

David H. Adams, M.D., chair of the Department of Cardiothoracic Surgery at The Mount Sinai Medical Center and national co-principal investigator of the CoreValve U.S. clinical trial said, “The CoreValve Trial investigators are very encouraged by our experience using the investigative CoreValve system to treat patients with severe aortic stenosis, and we are eager to fulfill the requirements of the Trial in hopes of offering the valve to more patients in the future.”

Read the full release from Medtronic here.

Find out more about the CoreValve device here.

Which Medical Device launches new anaesthetics device section

Mon, 23 Jan 2012 15:44:50 GMT

Which Medical Device is the authoritative voice for product information, review and opinion in the medical device sector, and we are delighted to add anaesthetics to our existing areas of expertise in cardiology, interventional radiology and orthopaedics. You can browse the new anaesthetics section here.

Dr Ian Nesbitt, Senior Editor for Anaesthetics and Consultant in Anaesthesia & Critical Care said, "increasingly, there are numerous new items of medical equipment available, yet only a limited ability to decide how useful they are in clinical practice. Which Medical Device offers an excellent opportunity for clinicians to read balanced, individualised views of equipment and to contribute their own opinions. This website is an exciting development, and should both simplify and speed up the process of selecting and evaluating equipment for individual and departmental use."

Dr Phil Haslam, Editor-in-Chief and Consultant Interventional Radiologist said, "anaesthetics and critical care is an important section for Which Medical Device, as this specialty uses many different devices ranging from anaesthetic machines and monitoring devices to nerve ablation devices and drainage catheters. There are numerous manufacturers and making the correct device choice is difficult but vital for optimal patient care.”

Have you used any of these anaesthetics devices? Or can you think of a device we haven't featured yet?

If so, we’d love to hear from you. We believe that clinicians want to know what devices are really like from colleagues who use them, and we depend on the reviews and comments of our members to help fellow clinicians make important decisions.

Members can comment on any device on the website, or suggest a product that you'd like us to feature.

Browse all anaesthetics devices here or suggest a new anaesthetics device to add to the site.

DePuy suspends distribution of custom devices following FDA warning

Mon, 23 Jan 2012 10:36:41 GMT

Johnson & Johnson subsidiary Depuy Orthopaedics has decided to stop selling all custom devices following an FDA letter warning. The FDA requires DePuy to file new new PMA or 510(k) applications for several components including:

1. PFC Sigma Knee System with titanium components and Global Advantage Shoulder System with titanium heads;

2. PFC Sigma Knee System components, sizes 2.5, 7, and 8;

3. PFC Sigma Knee System, 30 mm – 40 mm thick inserts;

4. Agility Total Ankle Prosthesis talar components with stems 0.35 inches and longer;

5. Agility Total Ankle Prosthesis talar stems that are round in cross-section and taper downwards;

6. The Agility Total Ankle Prosthesis augments;

7. Global humeral stems 18 mm in diameter;

8. Global Humeral Stems shorter than 120 mm in length;

9. TriFlange Acetabular Cups with outer diameters greater than 66 mm;

10. TriFlange Acetabular Cups indicated for cemented use;

11. Femoral heads that include a 14/16 taper;

12. Femoral heads with offsets greater than +12;

13. Acetabular hip system 14/16 taper adapters; and

14. Adapters to Stryker hip components.

DePuy wrote in a statement that while the company believes it had complied with FDA requirements, it has decided not to provide custom devices at this time.

Read the full FDA warning letter here.

Rise in knee replacements among 30 to 59 year-olds

Fri, 20 Jan 2012 11:54:13 GMT

A study reports a rise in the incidence of knee arthroplasty for primary osteoarthritis among baby-boomers in Finland.

The population-based study published in the journal Arthritis & Rheumatism reports that rates of knee replacement surgery in Finland's 30 to 59-year-olds rose between 1980 and 2006.

Dr Jarkko Leskinen, an orthopedic surgeon at Helsinki University Central Hospital, and colleagues found that Incidences remained higher among women during the whole study period, and most of the increase occurred among patients aged 50 to 59 years. Incidences grew more rapidly in low and intermediate volume hospitals.

The full study can be found here.

Find out more about knee replacement devices here.

Gore receives FDA approval for TAG Thoracic Endoprosthesis

Thu, 19 Jan 2012 14:05:47 GMT

The FDA has approved the GORE TAG Thoracic Endoprosthesis for endovascular repair of the descending thoracic aorta. The device is the first endovascular grafting system approved by the FDA to treat aneurysms of the thoracic aorta.

The full approval letter can be found here.

Find out more about the GORE TAG Thoracic Endoprosthesis here.

Device of the Year 2011 Winners Announced!

Mon, 16 Jan 2012 10:22:49 GMT

We’re delighted to announce the winners of the 2011 Which Medical Device of the Year Awards!

At the end of 2011 we asked our members to tell us the medical devices you simply can’t live without. Our judging panel enjoyed reading your nominations for the most significant, innovative and invaluable devices, and we are delighted to announce the winners in the categories of Cardiology, Interventional Radiology and Orthopaedics.

Many thanks to those of you who nominated devices and congratulations to Olof Brandone who has won six months’ free online subscription to SAGE journals online, courtesy of our partner SAGE.

Have you used one of these winning devices? Share what you think by adding a review. You can also join the conversation on Facebook, Twitter and Linkedin.

Dr Phil Haslam & Mr Craig Gerrand
Editors-in-Chief

And the winners are...

Cardiology

CrossBoss CTO Catheter
BridgePoint Medical

Our Senior Editor for Cardiology Dr Azfar Zaman commends this novel piece of technology with a good success rate in opening chronic occlusions: “it is a quantum leap in the world of CTOs”. Find out more

Interventional Radiology

Amplatzer Vascular Plug II
St Jude Medical

Our judges agreed this device provides easy, fast vessel occlusion replacing the use of multiple coils, and it is an invaluable device in emergency situations. Find out more

Orthopaedics

ALM Pelvic Replacement
Stanmore Implants

Additive layer manufacturing is likely to make a significant impact on the orthopaedic device industry in the next few years, and the convergence of digital technologies in imaging, surgical navigation and implant manufacture offers the promise of new, innovative solutions for patients. Find out more

Runner-up awards

Cardiology (joint runner-up)

SAPIEN Transcatheter Heart Valve
Edwards Lifesciences

Cardiology (joint runner-up)

CoreValve
Medtronic

The judges couldn’t decide between these two devices, which have both stood 'the test of time'. The medium term (five years) performance of both valves is sufficiently robust to hope that TAVI may well become the first preferred option in patients with aortic stenosis. Find out more

Interventional Radiology

Acculis Microwave Tissue Ablation (MTA) System
Microsulis

This device provides rapid tumour ablation with predictable zones and anecdotally less pain than radiofrequency ablation. Find out more

Orthopaedics

GENESIS II Total Knee System
Smith & Nephew

Our Orthopaedics runner-up award goes to the GENESIS II Total Knee System, in recognition of the high-flexion variation which may be of benefit for patients, particularly those who need to kneel. Although there is some debate about this, the Genesis II total knee system is our runner up because of the proven impact it has had on the lives of many patients, with over 5,000 implantations in the England and Wales National Joint Registry in 2011. Find out more

Special Commendations

Cardiology

In Cardiology, special mention is given to the WATCHMAN device from Atritech, which has the potential to improve lives by stopping the need for warfarin in patients with atrial fibrillation, and the ABSORB Bioresorbable Vascular Scaffold manufactured by Abbott Vascular, which we believe is the ‘next generation’ for stents: it promises much but needs to deliver.

Interventional Radiology

In Interventional Radiology, the judging panel also praised the NanoKnife System from AngioDynamics which promises to provide tumour kill whilst maintaining the integrity of blood vessels and other structures close to the tumour, allowing ablation in previously untreatable situations.

Recognition is also given to Gore’s EXCLUDER AAA Endoprosthesis. Our Specialist Editor Dr Andrew Platts praises this timely reworking of a great EVAR device, which uses the C3 delivery system: “still the same graft with ultra low migration and limb occlusion rates, but no longer the terror moment when you pull the string!”

Orthopaedics

Finally, our Orthopaedics judges awarded a special commendation to the KnifeLight manufactured by Stryker, an innovative product which allows surgeons to perform carpal tunnel release without either a traditional open approach or an endoscope by means of an illuminated knife. We liked the simplicity of the idea and the fact it appears to be safe and has published results.

The judges also applauded the Ceruleau Probe from NuOrtho: the only available probe (that we know of!) that allows the debridement of damaged cartilage without injuring healthy tissue and which can be connected to pre-existing electrosurgery machines. Although the long term clinical benefit remains unproven, we liked the principle that normal tissue should not be damaged during surgery, and the preclinical studies that showed this device is different to others on the market.

JACC study suggests increase in CeV events after TAVI

Tue, 10 Jan 2012 12:09:07 GMT

A study in the Journal of the American College of Cardiology found that the incidence of CeV events is highest within 24 hours of TAVI, but this risk may remain elevated for up to two months.

Patients who underwent TAVI were evaluated at baseline, at discharge, at 1 and 6 months, and yearly. Dr John Webb and colleagues at St Paul's Hospital in Vancouver concluded that their findings may have implications for patient selection and antithrombotic strategies.

The full report can be found here.

Find out more about the CoreValve device featured in this study here.

Research shows lower adverse-events for drug-eluting stents than bare metal stents in patients over 85

Wed, 04 Jan 2012 10:35:41 GMT

A report published in the Journal of the American College of Cardiology has observed lower adverse-event rates associated with drug-eluting stents (DES) versus bare metal stents (BMS) in older patients.

This national study compared the effectiveness of DES versus BMS among patients aged 85 or over undergoing percutaneous coronary intervention (PCI).

The full report can be found here.

Compare drug-eluting stents and bare metal stents online.

Study suggests RFA could be first-line treatment for early-stage HCC patients

Tue, 03 Jan 2012 16:40:17 GMT

A study published in The American Journal of Gastroenterology suggests that radiofrequency ablation (RFA) might be a first-line treatment for selected patients with early-stage Hepatocellular Carcinoma.

The report from Japan found that one in four patients with hepatocellular carcinoma treated with percutaneous radiofrequency ablation was still alive ten years later.

Dr Shuichiro Shiina and colleagues at the Graduate School of Medicine of the University of Tokyo concluded that "RFA could be locally curative, resulting in survival for as long as 10 years, and was a safe procedure. RFA might be a first-line treatment for selected patients with early-stage HCC."

The study looked at the Cool-tip ablation system manufactured by Covidien.

The full report can be found here

Find out more about the Cool-tip ablation system here

Study finds catheter-directed thrombolysis reduces the frequency of post-thrombotic syndrome

Thu, 22 Dec 2011 10:29:15 GMT

A study in the Lancet published to coincide with a presentation at the annual meeting of the American Society of Hematology in December 2011 suggests that additional catheter-directed thrombolysis reduces the frequency of post-thrombotic syndrome (PTS) and improves iliofemoral patency.

Tone Enden, M.D. from the University of Oslo in Norway and colleagues investigated whether additional treatment with catheter-directed thrombolysis using alteplase reduced development of PTS.

Read the full study in the Lancet online here

Find out more about thrombectomy devices:

Trerotola thrombolysis device

Rotarex System

Report finds colonic stents provide a bridge to surgery in malignant large-bowel obstruction

Thu, 22 Dec 2011 10:42:03 GMT

A report in the American Journal of Gastroenterology has found that colonic self-expanding metal stents (SEMSs) provide an effective bridge to surgery treatment in patients with acute malignant colonic obstruction.

Dr J. Jimenez-Perez at the Hospital de Navarra in Pamplona, Spain, and colleagues conducted the largest prospective series to date in patients with malignant colorectal obstruction to evaluate the effectiveness and safety of colonic self-expanding metal stents (SEMSs) as an alternative to emergency surgery.

The study looked at the use of the WallFlex colonic stent in 39 centres in thirteen countries.

The full report can be found here

Find out more about the WallFlex colonic stent here

Analysis indicates everolimus-eluting stents can result in improvements for higher-risk patients

Wed, 14 Dec 2011 13:52:33 GMT

Pooled analysis from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) randomized trials has been published in the Journal of the American College of Cardiology.

The study suggests that patients with short lesions in large vessels have low rates of MACE at 2 years after treatment with either EES or PES. In higher-risk patients with long lesions and/or small vessels, EES results in significant improvements in both clinical safety and efficacy outcomes.

The full report can be found here

Have you had experience of the XIENCE V Everolimus Eluting Coronary Stent? We'd love to know what you think.

Add your review to our device page here

BMJ report finds limited evidence comparing the effectiveness of hip replacement bearings

Tue, 13 Dec 2011 15:16:56 GMT

In a systematic appraisal of the published evidence reported in this week’s BMJ, Sedrakyan et al found that there is limited evidence comparing the effectiveness of different hip replacement bearings. The review was undertaken by the United States FDA in order to create a framework for the post-market evaluation of orthopaedic implants.

The authors examined 3254 abstracts and identified 18 comparative studies, and also reviewed national joint registry reports. They conclude that there is no evidence for improved outcomes in the group with alternative (i.e. metal on metal or ceramic compared with metal on polyethylene) bearings.

The full report can be found here.

Study suggests stent with biodegradable coating reduces risk of cardiac events

Sat, 10 Dec 2011 11:46:35 GMT

A Biosensors study suggests that a drug-eluting stent with biodegradable polymer coating can outperform a SES with durable coating.

The study, published in the Lancet, compared Biosensors' BioMatrix Flex drug-eluting stent with Johnson & Johnson's CYPHER Sirolimus-eluting Coronary Stent. The Biomatrix device reduced the risk of cardiac events associated with very late stent thrombosis, according to the company.

Read the full study in the Lancet online here

Have you had experience of these devices? We'd love to know what you think.

Please add a review to our device pages:

BioMatrix Flex drug-eluting stent

CYPHER Sirolimus-eluting Coronary Stent

Nominations now open for Device of the Year 2011!

Fri, 09 Dec 2011 16:41:03 GMT

It’s that time of year again when Which Medical Device invite you to tell us the device you think should receive a Device of the Year Award. We're asking our members and friends to nominate the crucial medical device you just can't live without!

Nominate your favourite device here. It's simple and quick and you will be entered into a prize draw to win a 6 month online subscription to ALL SAGE Journals Online, courtesy of our partner SAGE.

So if you can you think of a device that deserves recognition - whether it's because it's simple to use, does the job better than any other, shows real innovation or, most importantly, because it transforms the lives of patients, then submit your nomination now!

There will be one winner and one runner up from each device category, Cardiology, Orthopaedics and Interventional Radiology and the deadline for nominations is 31st of December so get yours in fast!

Our expert panel of judges will review the nominations and announce the winners early in the New Year.

Nominate your device here

Find out who won at the 2010 awards here

PleurX peritoneal catheter earns NICE recommendation

Tue, 29 Nov 2011 10:56:09 GMT

CareFusion has received endorsement from the UK's National Institute for Health and Clinical Excellence for its PleurX peritoneal catheter for the management of malignant ascites. Covidien also earned a NICE recommendation for its Pipeline device for the treatment of complex or large intracranial aneurysms.

Find out more about CareFusion's PleurX peritoneal catheter here

Watch a video demonstration of the catheter here

Newcastle's Tissue Engineering Centre aims to develop stem cell treatments for arthritis

Tue, 18 Oct 2011 22:15:22 GMT

Arthritis Research UK has launched a £6 million experimental tissue engineering centre led by Newcastle University. The aim of the project is ultimately to develop biological therapies for osteoarthritis using stem cells. The centre is led by Newcastle University but is a collaboration with The University of Aberdeen, Keel University/The Robert Jones and Agnes Hunt Hospital and the University of York. Professor Andrew McCaskie, Centre Director is hoping to develop treatments which would remove the need for conventional joint replacement by, for example, intervening earlier on in the disease process with arthroscopic techniques.

For the full press release, look here.

MHRA publishes review of medical device incidents in 2010

Sun, 09 Oct 2011 16:37:00 GMT

According to the UK Medicines and Healthcare products Regulatory Agency (MHRA), 2010 saw a total of 10,280 reports of adverse incidents, 13% more than 2009. In 177 of 279 cases where a fatality was reported, there was no established link with the device. Where there was a serious injury, no link with the device was identified in 1,359 of 2,022 cases. 730 manufacturer undertakings were made to improve designs, processes or quality systems.

The range of medical devices supervised by the MHRA is wide and includes assistive technologies, diagnostic devices, pacemakers as well as cardiovascular, imaging and orthopaedic devices. In the latter category, advice about metal-on-metal hip implants featured in 2010, and the MHRA works with the National Joint Registry and the British Orthopaedic Association to ensure a collaborative approach to monitoring devices.

The full report can be found here.

National Joint Registry of England and Wales publishes 8th Annual report

Thu, 15 Sep 2011 20:59:25 GMT

The 8th NJR Annual report was published today at the British Orthopaedic Association Congress in Dublin. The headline figures include:

The largest ever number of data submissions and patient consents
Contains 1.1 million records
Now includes ankle replacements
Patients undergoing hip and knee replacement in NHS hospitals have lower ASA gradings than those in independent hospitals, NHS treatment centres and ISTCs.
Seven year revision rates after hip replacement were 3% for cemented prostheses, 11.8% for resurfacings and 13.6% for stemmed metal on metal bearings.
In knee replacement, seven year revision rates were 3.8% for cemented prostheses, 4.8% for hybrid or uncemented, 16.6% for unicondylar prostheses and 20.4% for patellofemoral implants

For the full report look here.

Medtronic agrees to independent scrutiny of Infuse Bone Graft

Tue, 30 Aug 2011 21:58:51 GMT

Following scrutiny from a US senate committee, Medtronic announced this month that it would give data and $2.5m funding to Yale University to review the safety of their Infuse Bone Graft product. It had been alleged that Medtronic had failed to mention side effects of the product which is a recombinant bone morphogenetic protein 2 (rhBMP-2) used to stimulate bone growth after spinal surgery. The arrangement is intended to allow two fully independent assessements of the data and is unusual in that access to full patient data has been granted rather than the summaries which are normal practice.

For the press release from Medtronic, look here.

For an overview from the BMJ, look here.

Professional societies issue position statement on transcatheter valve therapy

Thu, 30 Jun 2011 20:24:10 GMT

The American College of Cardiology Foundation (AACF) and the Society for Thoracic Surgeons (STS) have published a combined statement on the implementation of transcatheter heart valve replacement. They recommend a combination of good practice measures including team working, data collection in trial settings, nominated centres and good training. This is to be applauded, and reflects concerns about the potentially transformational nature of this kind of intervention, offering therapy for patients who may be considered too unwell for traditional open approaches.

The Edwards Sapien heart valve is one such device. It went on sale in Europe in 2010, and a decision from the FDA in July 2011 is expected to be positive.

Johnson and Johnson Cordis exits the drug eluting stent business

Mon, 20 Jun 2011 22:19:01 GMT

Competition in the drug-eluting stent market has lead to the decision from Johnson and Johnson to stop making the heart devices which it pioneered. This part of the market has been seen as particularly difficult because of law suits around patent infringement. The Cypher stent had been losing market share, and this announcement will also see an end to the development of the Nevo stent, acquired with Conor Medsystems in 2007. The company will continue to focus on devices such as the Exoseal vascular closure device and the Incraft stent graft system for abdominal aortic aneurysm.

Boston Scientific, manufacturers of the Promus coronary stent system saw a rise in its stock price following the announcement.

College of Surgeons recommends improving the dissemination of knowledge about new technologies

Wed, 15 Jun 2011 20:58:00 GMT

The Royal College of Surgeons of England published a report today examining barriers to innovation in surgery and highlighted the fact that surgical studies receive only a small proportion (1.5%) of the total medical research budget. The report makes 15 recommendations including more centralised support for surgical studies, the incorporation of research modules into surgical training, and the establishment of networks of surgical researchers. The one we liked best however, was that the Department of Health and the surgical profession should explore how the best information on new technologies might be disseminated to all relevant surgeons, because that is in keeping with the aims of Which Medical Device. However, there is no doubt that the fundamental differences between surgery and other specialties mean that it is unlikely that surgical studies will ever overtake medical ones (eg new drug trials) in number. The surgical craft requires long training, is highly operator dependent (ie often depends on many individualised decisions and skills which are difficult to allow for in clinical trials) and the time demands of surgical practice make it difficult to combine with a formal academic interest.

Would you still do a metal on metal hip resurfacing? A roundup of hip resurfacing devices

Mon, 06 Jun 2011 22:19:23 GMT

The last few months have been particularly difficult for many involved in hip resurfacing. The flush of enthusiasm for the technology seen five or so years ago has been replaced by a race for the exit for many. Problems with the ASR device in particular have made the headlines and mainstream media, and there is the spectre of further failures to come following the enthusiastic implantation of large bearing metal-on-metal hip replacements on standard stems : the term trunionosis* has been coined and is rapidly being adopted into the orthopaedic vernacular.

It may therefore be an ideal time to review the hip resurfacing devices which have been, and still are available and we have product descriptions for ten of these here.

The list includes devices with established track records, devices which have yet to prove themselves, and devices which have been withdrawn or which may have poorer results than others. In the first category, the Birmingham Hip Resurfacing is perhaps the best established device, with excellent published results. However, it is likely that even enthusiasts are limiting their indications, avoiding younger patients and those needing smaller sizes. Socket placement remains a critical part of the procedure, as experience shows it is particularly important to avoid open sockets and impingement. and patients should be carefully followed up. The ADEPT hip resurfacing is a very similar device, with similar (albeit shorter term) results; the MITCH resurfacing from Stryker is also similar, coming as it does from the same manufacturer, but has few published results to speak of so far, being preentry by ODEP criteria. The Conserve Plus has good results from a single centre and an ODEP 5A rating, but is yet to be widely adopted.

The ReCap Hip Resurfacing has a UK ODEP 3A rating, but appears to have a higher revision rate in the Australian and England and Wales National Joint Registries than the Birmingham Hip Resurfacing. The Cormet 2000 has an ODEP 5B rating, but also has higher revision rates in these registries.

Unknown quantities amongst hip resurfacings include the Minimally Invasive Hip Resurfacing, which is yet to publish results. The ACCIS Hip from implantcast has a unique ceramic surface engineered finish which shows great promise, but for which published results are also awaited.

The ASR Hip Resurfacing has been withdrawn from the market, and the Durom socket withdrawn from sale in the USA. The US version of the latter was a little different from that in the rest of the world, but results elsewhere have not lived up to the promise of the smaller metasul bearing.

It seems likely therefore that the future will see far fewer metal-on-metal hip resurfacings being implanted, and that some of these devices will no longer be used. For some this opens up a gap in the market, which may be filled by devices which are new but also may be unproven (eg short stem hip replacements, ADM X3). It is important that the lessons of hip resurfacing are learned if the potential for similar issues with some of these devices is to be avoided in future.

June 2011.

*Trunionosis The phenomenon whereby wear particles are generated at the trunion or interface between head and stem in a modular hip system. The phenomenon may be exaggerated where there is a large head bearing, and the frictional torque generated at the joint surface is correspondingly large, or where the assembly includes a collar or sleeve between the trunion on the stem and the femoral head.

Editor's note.

Hart points out that this term is misleading because most of the wear occurs on the head side of the taper, rather than on the femoral stem, or trunion. This is important because many meta-on-metal bearing revisions might be possible without changing the stem.

Following on from C4 Dispatches programme, this week's BMJ explores device regulation

Sun, 22 May 2011 18:35:46 GMT

This week’s BMJ is sobering reading for anyone interested in medical devices. In an editorial by Peter Wilmshurst (who is being sued for comments he allegedly made about the STARFlex device) and a series of feature articles, the present regulation and approval processes of medical devices in the United Kingdom and Europe are heavily criticised. The article examines the European device approval process by which privately funded companies determine whether devices meet regulatory standards, and compares it to the US system where the correspondence between regulators and companies is freely available on the Internet (here at Which Medical Device, we have found these letters extremely useful sources of information). Regulators are not required to prove a device has a clinical benefit in Europe, only that it does what it is said to do. The ASR hip features heavily, as in the Dispatches programme earlier in the week. Other devices mentioned include the Birmingham Hip Resurfacing, the ASR XL large metal on metal bearing, and the Sapien heart valve.

The difficulty in obtaining data about devices in Europe extends to recalls. One researcher depressingly found it almost impossible to obtain information about the reason for UK device recalls.

But how to proceed? The relationship between clinicians, regulators and industry is necessarily complex. Clinicians are essential to the development of new devices and have to have a role in their development, but the incentives involved may even unintentionally skew the reporting of results. Clinicians must bear in mind that they are the often the last line of defence between patients and industry and proceed with caution when new devices are involved, whatever the regulators and the companies say. The disincentives for companies to report early problems with devices are similarly powerful – there may be a lot to lose in terms of reputation and financial cost.

Furthermore, it is clear that developing and marketing a new hip replacement, an area in which new devices may only represent an incremental improvement in outcomes for patients, has a different risk/benefit profile to new devices for patients with a serious condition for which there is no other good treatment. Patients need to have access to the potential benefits of new technologies, but not at any cost.

The flurry of media activity around this issue has lead to questions being asked in Parliament and may, in due course, lead to a change in regulation. However, it remains to be seen whether the regulators can improve safety without stifling innovation. Making public all available information about medical devices would be an excellent first step.

Channel 4 Dispatches featuring medical devices

Tue, 17 May 2011 22:24:38 GMT

The UK Channel 4 Dispatches programme on Monday 16 May took on the issue of failing medical devices, with a predictable blend of facts, opinion and patient stories. The programme covered the ASR hip resurfacing, a Medtronic implantable pacemaker/defibrillator and a cochlear implant manufactured by Advanced Bionics, but it was the ASR hip which received the most coverage. The programme makers interviewed Hartlepool surgeons who had implanted the device and were consequently the first to notice early failures. The relationships between surgeons and device companies in the United States in particular came under scrutiny. The main thesis of the programme was that medical devices should be better regulated, need better clinical evidence before coming to market, and that the present arrangements by which devices can be licensed because they are substantially similar to others needs an overhaul – this is a theme that the BMJ had developed late last year.

Which Medical Device (@whichmeddevice) took part in the accompanying Twitter debate (@C4Dispatches, #Dispatches, #HipOp) along with patients, journalists and a fair number of lawyers. Some patients were concerned about upcoming joint replacement operations and some were actively promoting the devices they had in-situ (notably the Birmingham Hip Resurfacing). We were happy to point twitterers to the content on our website, including the product descriptions of a range of hip resurfacings. We were pleased to see the point was made that clinicians and patients need access to the best objective information about devices.

UK users can view the documentary until Monday June 6th via Channel 4's 4oD service.

Synthes to be acquired by Johnson and Johnson in $21bn takeover

Sat, 30 Apr 2011 07:23:45 GMT

The US healthcare corporation Johnson and Johnson has agreed to buy the Swiss orthopaedic implant manufacturer Synthes in a deal worth $21.3 bn (£13bn). The deal is due to complete in the first half of 2012, subject to shareholder and regulatory approval. Some have speculated that this helps Johnson and Johnson manage the product recalls it has had to deal with in the last year (including the ASR hip), and Synthes has had a reputation as having the highest profit margins in the industry. The acquisition may push Johnson and Johnson’s share of the orthopaedic trauma market to around 54%, a market which is expected to grow faster than that for hip and knee replacement, and will also increase their presence in the market for spinal implants.

Synthes has more than 11,000 employees and sales last year of $3.69 billion. Synthes chairman Hansjoerg Wyss has a significant stake in the company and may now become Swizerland’s richest man. Until this deal was announced, Smith and Nephew had also been a target for takeover by Johnson and Johnson.

What's available in Short Stem Hip Replacements

Sat, 30 Apr 2011 17:08:25 GMT

The quest for bone preservation in hip arthroplasty has lead to the development of femoral implants with relatively short stems. The thinking behind these includes not only the preservation of proximal bone stock but possibly also less stress shielding of the proximal femur, ease of revision, reduction of the risk of thigh pain and facilitating minimally invasive surgery, particularly when using an anterior approach. As hip resurfacing declines in popularity, it is likely that there will be a corresponding increase in the number of short stem femoral components in use. We’ve had a look at what’s available.

Short stem hips come in a number of designs and design philosophies, although most are titanium and have hydroxyapatite coatings. At the outset, it might be helpful to mention the Birmingham Mid-Head Resection Prosthesis (BMHR). This device involves resection through the base of the femoral head, has a short conical stem and is designed to be inserted into a reamed cone in the femoral head and neck. It is argued that preserving some of the base of the femoral head results in a shape which is better suited to loading the proximal femur. The stem has a 12/14 taper, and the head and acetabular components are identical to that of the Birmingham Hip Resurfacing, which has avoided some of the problems seen in other metal on metal bearings. Although there are early good results from the originator, long-term results are awaited.

Other short stem devices can be categorized as those with a collar, those without, straight or curved stems, or those which are shortened versions of stems already on the market. The device with the longest track record (98.2% survival at ten years) is the Mayo stem. This is a neck-retaining device which has a proximal wedge-shape for fixation, and the tip touches the lateral cortex, which is at risk of perforation during insertion. The original grit blasted finish has been superseded by a hydroxyapatite coating.

One of the few short stem devices with a collar is the CFP stem from Link, which is an evolution of the Pipino stem. This device has good medium term results (99% survival at 74 months), and the manufacturers report 25,000 implantations since 2000.

Of the remaining collarless devices, the Corin MiniHip and the Collo-MIS stem both have a similar, tapered, curved geometry without a shoulder, but neither have published results. The Aida Short Stem from Implantcast has a more tapered and angled tip to the stem, but again has no published results. Those considering using a new device should review the experience of the CUT Femoral neck prosthesis from Orthodynamics. Although one series demonstrates good results, others have struggled with alignment and offset.

The Metha short hip stem from Braun has a similar geometry to the Aida short stem, but is one of the few of these devices to have an ODEP 3A rating. The Proxima Short Stem Hip from Depuy has a proximal fit and fill geometry, with a larger lateral profile than other stems, but is shorter than some, so care needs to be taken with varus/valgus positioning. It is rated pre-entry by ODEP.

The Silent hip from Depuy is a short, straight stem device, which remains in clinical trials.

The remaining devices, the Fitmore from Zimmer, the SMF from Smith and Nephew and the Taperloc and Balance Microplasty stems from Biomet more closely resemble short versions of established devices, and in the case of the Taperloc and Balance Microplasty stems are overtly so. Once more, there are no or few published results.

To summarise, although there are potential benefits to these shorter stems, particularly for enthusiasts of the anterior approach, the majority of these devices do not have long term results, and there is a need for careful collection of data and clinical trials. In the rush to replace some hip resurfacing devices as an option for younger patients, care should be taken when considering other unproven implants.

A brief history of EVAR and current devices

Fri, 25 Mar 2011 00:00:00 GMT

Dr R Allison, Interventional Fellow, Freeman Hospital, Newcastle upon Tyne, UK.
Dr J Rose, Consultant Interventional Radiologist, Freeman Hospital, Newcastle upon Tyne, UK.

Introduction

The number of endovascular aortic repairs (EVARs) performed worldwide has increased exponentially since its inception at the start of the 1990s. The aortic stent graft itself has evolved from basic tubes to the wide range of modular devices, available in a vast array of sizes, currently in use today. Well established devices with proven efficacy compete with new entries to the market and novel concepts in stent design.

This concise review focuses on the evolution of the endovascular graft and summarises the devices currently in use today.

The evolution of aortic stent-grafts

The first stent grafts used were simple aorto-aortic tube grafts with balloon expandable stents stitched to either end. Initial problems with distal sealing, due to progression of the aneurysmal process in the distal aorta, resulted in a high long term failure rate. This led to the development of devices to fit the iliac vessels and allow a more secure distal seal; initially an aorto-uni-iliac configuration was combined with a surgical femoro-femoral cross-over graft.

1994 saw the introduction of commercially produced bifurcated devices which enabled many more endovascular centres to get involved in the procedure and a shift towards the use of bifurcated devices worldwide. The early single component devices soon gave way to modular component systems, many of which have evolved through a number of iterations to become the devices of choice today.

Over the years the importance of a number of concepts relating to device design has become apparent. Broadly speaking these involve either the delivery system or the stent itself. Delivery systems, once rather cumbersome and rigid have become more flexible, allowing access in extremely tortuous vessels, better proximal alignment and improved accuracy of stent deployment. In addition, re-deployment of the proximal fixation system is now possible. Regarding the proximal stent, supra- and infra-renal fixation systems have evolved, reducing stent-graft migration rates. Evolution of nitinol based systems has produced more conformable devices and will probably result in a reduction in long term stent fractures.

Main bifurcated devices in commercial use

The way device use is regulated varies worldwide. In the USA this is controlled by the Food and Drugs Administration (FDA); within the European Economic Area (EAA) devices must bear the ‘CE’ conformance mark for consumer safety, health and environmental requirements.

Talent – (Medtronic Vascular, USA)
The Talent is a modular (2 piece) stent-graft that has been used worldwide for over 10 years. The introduction system has a hydrophilic coating to reduce friction in tortuous iliac vessels and has stood the test of time with regard to ease of use and accuracy. The graft is a nitinol and polyester fabric graft construction with a non-barbed suprarenal fixation stent. There has been a reduction in popularity in Europe since the Endurant became available. FDA approved & CE marked.

Endurant – (Medtronic Vascular, USA)
This is currently the most widely used device in Europe. Modular 2-piece design, nitinol based with similar polyester graft to the Talent device. Large proximal uncovered nitinol stent; stent configuration in body and limbs designed to increase flexibility and conformability. Small caliber introduction system (18F) facilitates percutaneous EVAR. Unique proximal cap so that the covered body can be deployed prior to releasing the proximal uncovered fixation stent.
CE marked and now also FDA approved since Dec 2010.

AneuRx AAAdvantage – (Medtronic Vascular, USA)
This device has been around since the early days of EVAR, with over 15 years of use and the design now in its 7th generation. Modular two piece device with infra-renal fixation. No longer in common use in Europe but popular in the USA. FDA approved & CE marked.

Zenith Flex - (Cook, Denmark)
Until the release of the Endurant this modular (3 piece) stent-graft was the most widely used stent-graft in Europe and there is a large world-wide experience over 15 years. Large proximal uncovered Gianturco stainless-steel stent; long body design with Z-stent configuration in body and limbs. Flexible 20-24Fr introduction system with a long tapered proximal cap; the covered body can be deployed prior to releasing the proximal fixation stent. Safety wires prevent inadvertent early release of the top cap. Robust device with good long term safety profile. FDA approved & CE marked

Zenith Low Profile (LP) - (Cook, Denmark)
New modular (3 piece) device, launched in 2010 as an addition to the Zenith series. The delivery system is an 18F hydrophilic, braided sheath. Like the Endurant this system facilitates the minimally invasive pure percutaneous approach. The new graft remains Dacron but is held on a nitinol frame with stent shapes that encourage conformability. There is a small top cap above the long suprarenal bare stent which is held in check by a very robust safety wire prior to satisfactory release of the main body. CE marked.

Gore Excluder (WL Gore, USA)
Available world-wide since the early days of EVAR with continuous design improvements and good long-term follow up data. Modular two piece nitinol based device with infrarenal fixation. Longer body, 20Fr profile and larger contralateral limbs available. Recent introduction of a new ‘C3’ delivery system allows repositioning of the proximal sealing stent after initial deployment. This can be a real life saver in the short or difficult proximal aortic necks. FDA approved & CE marked.

Powerlink (Endologix, USA)
Employed in Europe since 1999, the Powerlink device is a unibody bifurcated device. A self-expanding single wire nitinol endoskeleton is covered with ePTFE fabric. The Powerlink is implanted through one surgically exposed femoral artery and a contralateral 9 Fr puncture. FDA approved & CE marked.

Aorfix (Lombard Medical, UK)
Two piece modular infrarenal device, which can be very useful in angulated proximal necks and tortuous iliac anatomy. A proximal (robust and barbed) fixation stent forms a fish mouth when compressed. The unique stent design uses encircling nitinol rings to provide maximum flexibility of the entire stent-graft. Excellent conformability to angulated anatomy. CE marked.

Anaconda (Vascutek Terumo, UK)
The proximal orifice of this 3 piece modular infrarenal device can also form a fish mouth configuration. But in this case proximal fixation is with a double-stent ring which is uniquely leashed to the central introduction cannula. This particular mechanism allows for repositioning of the proximal device in difficult anatomy. The body of the device is largely unstented but nitinol rings in the limbs allow for excellent conformability to angulated anatomy. CE marked.

Ovation (Trivascular, USA)
This is a very new 3 piece device, with the first investigational clinical case implantations in September 2010. The stent graft body (with suprarenal stent) is delivered in a 14F (outer diameter) system, designed to expand the patient population suitable for EVAR by addressing a wider range of diseased anatomies. The proximal seal is provided by hollow rings in the fabric which are expanded by polymer injection after deployment. The stent-graft limbs are inserted separately. CE marked.

Incraft (Cordis, USA)
This stent-graft is undergoing a preliminary trial in Europe. No available images or information regarding design other than the fact that the introduction system is 14F.

Final Thoughts

Over the last 20 years the volume of patients treatable via an endovascular approach has grown consistently, mainly due to advancements in device design. Classically this revolved around new generations of existing devices, with a move towards lower profile delivery systems. Importantly this has enabled EVAR in increasingly tortuous iliac anatomy and also allowed an entirely percutaneous procedure, shown to reduce wound complications compared to surgical cut-downs (1). With increased market place competition, greater number of manufacturers and dedicated research teams, increasingly novel design concepts are being seen; including a yet to be launched polymer fillable EVAR system developed by Nellix Endovascular (USA). No doubt this technology will continue to evolve for the next 20 years and more.

References

1. McDonnell C O: Percutaneous endovascular abdominal aortic aneurysm repair leads to a reduction in wound complications, Irish Journal of Medical Science; 2008 March; Volume 177(1), 49-52

2. Rose J: Stent-grafts for unruptured abdominal aortic aneurysms: current status. Cardiovasc Intervent Radiol; 2006 May-Jun;29(3):332-43

Device and stent specifics taken from currently available manufacturer’s data/IFU.

This article was published as 'Tools of the Trade' in the March/April edition of IR News, published by the Society of Interventional Radiology and was contributed by Dr. Phil Haslam, Interventional Radiology Editor of Which Medical Device.

Can you help to source renal artery RF ablation therapy equipment?

Thu, 24 Mar 2011 00:00:00 GMT

Can you help to source renal artery RF ablation therapy equipment? Senior radiographer and Which Medical Device user warkworth16 has asked for assistance in sourcing the equipment to perform renal sympathetic nerve ablation therapy to treat his wife who suffers from severe refractory hypertension:

"I am currently employed as a Lead Senior Radiographer at a major North East Hospital.

“My wife is suffering from severe refractory hypertension, despite excellent compliance with several anti-hypertensive agents her blood pressure is typically 280/140 mmHg, with a resting tachycardia of around 140 bpm. She has a severely dilated left ventricle, with globally impaired left ventricular systolic function, and has nephritic range proteinuria.

“We were made aware of the renal sympathetic nerve ablation therapy, but she has been turned down for this procedure at Barts. Due to difficulties establishing the renal ablation service, and the option of Harley Street treatment would not be funded by her PCT.

“The hospital I am employed in has a large interventional unit, and despite several of my Consultant colleagues being keen to carry out this procedure, the equipment required cannot be sourced.”

“There has been a significant deterioration in my wife’s condition in the last few months, and as this ablation therapy is the only chance she has of any improvements in her health, I would appreciate any help that can be given in sourcing the equipment necessary to allow interventional colleagues to carry out this procedure.

“Thank you in advance for any assistance that can be offered.”

Update - 17 May 2011

We are please to report that following a campaign by WMD and local Interventional Radiologists we managed to source treatment in London for the patient with refractory hypertension (link to warkorths comment). The patient was treated with Ardian/Medtronics symplicity catheter system for renal RF denervation. Since then her BP has decreased by 40mm Hg systolic and diastolic, tachycardia decreased and her excercise tolerance has increased from a few yards to 1.5 miles. Thank you to everyone who helped with this.

Surgeons cautioned about large diameter metal on metal hips

Tue, 08 Mar 2011 00:00:00 GMT

The British Orthopaedic Association and British Hip Society today published a statement about large diameter metal on metal bearing hip replacements. Several series presented at the British Hip Society Conference demonstrated high revision rates – with the ASR device demonstrating a 49% 6 year revision rate, and others a rate of 12-15% at 5 years. This is in keeping with data already included in the 7^th UK National Joint Registry Report.

Possible reasons for failure included damage at the taper junction between the large head and the stem, wear at the bearing surface and stem corrosion (of uncemented stems). The need to follow up patients for a minimum of five years and possibly the life of the prosthesis was emphasized, and surgeons were cautioned about further implantation of these devices.

Read the statement in full.

BCIS Advanced Cardiovascular Interventions 2011 report

Mon, 14 Feb 2011 00:00:00 GMT

Advanced Cardiovascular Interventions, the annual meeting of UK interventional cardiologists, held in London was a 3 day programme of live cases, lectures and industry sessions. The highlight was the Keynote Lecture given by Kenneth Chien from Massachusettes General Hospital, Boston USA. Professor Chien gave a tour de force of progress in the world of stem cell therapy. Eloquent and enlightening, he gave the gathering a glimpse of the (not too distant) future where injection of prepared and programmed stem cells could effectively repair damaged heart muscle.

Industry sessions focussed on antithrombotic therapy and development of new products for use in coronary intervention.

Dr Carmen Walbert, Medical Director of Medtronic gave an overview of the future role of the interventionalist. She touched on development of the new Integrity range of intracoronary stents with a new coil designed to enhance delivery. She gave an overview of the complete range of Medtronic products in the field of cardiovascular disease. This ranged from stents designed for deployment in the pudendal artery for erectile dysfunction, radiofrequency ablation for resistant hypertension, leadless pacemakers and of course, the Corevalve for the percutaneous treatment of aortic stenosis.

Dr Keith Dawkins, Senior Vice President and Chief Medical Officer of Boston Scientific informed us of the development of the Element family of coronary stents designed to be deliverable, visible and with greater radial strength. We were told that the company had acquired Sadra, a company making aortic valves for percutaneous deployment through an 18F catheter. One novelty of this product is the ease with which it can be placed in position or withdrawn, even after deployment, if position is not ideal.

Dr Sandra Garcia, Marketing Manager, Cordynamic BU Marketing Manager, displayed 2 products for use in the highly thrombogenic milieu of primary PCI. The Hunter thrombectomy catheter is a 6Fr device with the largest inner lumen when compared to competitors. The Amicath is a dual lumen balloon for injecting drugs or contrast beyond an occluded vessel for visualisation distal to the occlusion and/or treating or reducing the “no reflow” phenomenon.

Mr Richard Rapoza, Divisional Vice President and General Manager, Abbott Vascular presented data on the Bioresorbable Scaffold programme. The first generation has undergone thorough evaluation in laboratory testing and the First in Man studies were completed last year in Europe. This is an exciting area and has the potential to transform the field of coronary intervention.

Mr John Shulze of Biosensors Europe, gave the gathering an insight into new technologies for application of drugs onto stent platforms without the need for a polymer coating. Future products could deliver anti restenotic drugs on the abluminal surface and antithrombotic drugs on the luminal surface.
In summary, this was a hugely informative and successful meeting for clinicians and industry.

Dr. Azfar Zaman, Cardiology Editor

DIY implant brings hope to sufferers of Marfan's syndrome

Thu, 10 Feb 2011 00:00:00 GMT

As reported in The Engineer, UK engineer and Marfan’s syndrome sufferer Tal Golesworthy has developed a unique solution to combat one of the effects of the disease.

A serious complication associated with Marfan’s syndrome is aneurysmal dilatation or dissection of the ascending aorta. The traditional treatment for this is open repair with replacement of the aortic valve and ascending aorta. This procedure has significant morbidity and mortality and then requires lifelong anticoagulation.

An alternative is to place an external support around the aorta. Early attempts at producing aortic supports by US surgeon Francis Robicsek failed due to the difficulty of accurately replicating the shape of the patient's aorta.

However, drawing on his background in research and development engineering, Golesworthy initiated the EARS (External Aortic Root Support) project to establish the feasibility of scanning the heart structure and using advances in computer-aided design and rapid prototyping to produce an accurate 3D model of the patient's aorta around which an aortic support could be tailored to fit.

Two years later Golesworthy became the first patient to have the new aortic support implanted and it has now been implanted successfully in more than 20 patients. The device completed its clinical trial in June 2009 and is now commercially avaialble as the ExoVasc distributed by Exstent Ltd.

Ten-year results show effectiveness of resurfacing technology

Thu, 03 Feb 2011 00:00:00 GMT

The January edition of the British Volume of the Journal of Bone and Joint Surgery carries ten year results of a single series of Birmingham Hip Resurfacings from Ronan Treacy, one of the designers and a long term advocate of the device. This series of 144 resurfacings followed up at ten years include his personal “learning curve” and some of the failures relate to technical aspects (such as cup anteversion), the importance of which has only become apparent over the last few years. Patients in the series are predominantly male, for whom the ten year survival of the implant was 98.0%. Problems in the 37 female patients included 8 failures, amongst which were 3 infections and a revision required in one patient who was 70 at the time of resurfacing – not many surgeons would offer resurfacings to patients of this age.

For comparison, the seventh UK National Joint Registry report quoted 5 year revision rates in males under 55 years as 4.4% (3.2% to 6.0%) for cemented hip implants, 4.0% (3.1% to 5.1%) for uncemented implants, 2.6% (1.7% to 3.8%) with hybrid, 5.6% (4.5% to 6.9%) with hip resurfacing (within which group the BHR had the best results – see also results of Conserve Plus – 88.5% survival at ten years (Amstutz et al, 2010)) and 6.4% (4.5% to 8.9%) with large bearing metal on metal hip replacement. The point is made however, that these are 10, rather than 5 year results. In this and other series, smaller components are associated with poorer outcomes.

So what to do when faced with a young patient with hip osteoarthritis? There are alternative approaches (eg custom femoral stem, 97.3% overall 10 year survival, (Muirhead-Allwood 2010), but whether or not you choose a Birmingham Hip Resurfacing, may relate to whether or not you are a believer.

References:

No authors listed. National Joint Registry for England and Wales: 7th Annual Report 2010. Downloaded 29th January 2011.
Amstutz HC, Le Duff MJ, Campbell PA, Gruen TA, Wisk LE.
Clinical and radiographic results of metal-on-metal hip resurfacing with a minimum ten-year follow-up.
J Bone Joint Surg Am. 2010 Nov;92(16):2663-71.
Muirhead-Allwood SK, Sandiford N, Skinner JA, Hua J, Kabir C, Walker PS.
Uncemented custom computer-assisted design and manufacture of hydroxyapatite-coated femoral components: survival at 10 to 17 years.
J Bone Joint Surg Br. 2010 Aug;92(8):1079-84.

Device of the Year 2010 - winners announced!

Tue, 18 Jan 2011 00:00:00 GMT

We ended 2010 by asking our members and friends to vote for our Device of the Year award and identify the crucial medical device that you can’t live without. We're delighted to announce the winners in the categories of Interventional Radiology, Orthopaedics and Cardiology. Many thanks to those of you who nominated devices.

Interventional Radiology

First place goes to Ardian's Symplicity Catheter System. A novel method of renal sympathetic denervation by catheter delivered RF ablation, this device caused a stir in late 2010 with the publication in The Lancet of the Symplicity HTN-2 Trial. We feel this device, and devices like it, have the potential to transform the lives of millions of people with resistant hypertension.

The runner up is the DC bead from Biocompatibles - a way of delivering targeted chemotherapy to colorectal liver metastases with reduced toxcity compared with standard TACE, thus prolonging many patients' lives.

Orthopaedics

The winner in the Orthopaedic category was the Exeter hip from Stryker, recognising the fortieth anniversary of the first implantation and a million hips implanted worldwide. There is no doubt that the device has transformed the lives of patients and its results continue to exceed those of others.

The runner up was the ACCIS hip from Implantcast. In a year in which the shine went off metal on metal bearings, the innovative ACCIS hip technology offers a ceramicised metal-on-metal articulation which avoids the release of metal ions, offering an alternative option to hip resurfacers everywhere.

Cardiology

We have joint winners in the cardiology category - two TAVI (transcatheter aortic valve implantation) devices. The SAPIEN from Edwards Life Sciences and Medtronic's Corevalve represent a quantum leap forwards from open-heart surgery to a percutaneous approach and our Cardiology editor was unable to separate them on performance.

The runner up is the GuideLiner from Vascular Solutions - a rapid exchange, highly flexible guiding catheter allowing excellent support for stent delivery close to the lesion.

Have you used any of the winning devices? Let us know your opinion by submitting a short review.

Will 2011 be an austerity year for healthcare? "Premium" implants may not add value.

Thu, 30 Dec 2010 00:00:00 GMT

In a paper in the January 2011 issue of Clinical Orthopaedics and Related Research, Gloe et al have used a community joint registry in an attempt to identify whether "premium" implants demonstrably add value to hip and knee replacement procedures. "Premium" knee replacements were defined as mobile bearing, high flexion, oxidised-zirconium femoral components or cross linked polyethylene. "Premium" hip replacements included those with ceramic on ceramic, ceramic on polyethylene or metal on metal bearings. Unsurprisingly perhaps, younger patients were more likely to have received a "premium" implant, but there was no difference in the cumulative revision rate, although there were fewer revisions for dislocation in the "premium" hip group, in which large bearings were used more frequently.

The authors make the point that several papers have shown no obvious superiority of high-flexion knees, mobile bearing knees, oxidized zirconium femoral components or moderately cross-linked polyethylene inserts, compared to standard lower cost implants. However, they also point out that more follow up is needed and their study could not assess any functional benefit from "premium" implants.

We think 2011 could see more studies along these lines, and a renewed focus on value for money. What do you think? Please comment on our forum...

The best medical device of 2010?

Tue, 14 Dec 2010 00:00:00 GMT

Good products and services deserve to be acknowledged and rewarded, so Which Medical Device is ending 2010 by asking our members and friends to vote for our Best Device of the Year award and identify the crucial medical device that you can’t live without.

Can you think of a device that stands out because it is simple to use, because it does the job better than any other, because it is innovative or, most importantly, because it transforms the lives of patients?

While we’ve got some definite ideas about contenders, I’m sure that there’s plenty more to recommend as well. So over the next fortnight, we’ll be looking for your suggestions for worthy winners in this area.

There’s no restriction on which medical discipline or type of device so please let us know your nomination by contacting us with one sentence saying why you think your device is a worthy of an award, our expert panel of judges will then pick the best of the rest and publish the results over the Christmas and New Year break.

Write a review and win an iPad!

Thu, 18 Nov 2010 00:00:00 GMT

We want to reward our best contributors and are therefore offering an Apple iPad for the best review and iPod touch for the best user comment before Monday 13 December 2010.

Which Medical Device is an independent review website for medical devices. We aim to provide users with all the information they need to make decisions about which devices to use. This information includes independent user reviews, editorial comment, discussion forums and information provided by manufacturers. We believe that users want to know what devices are really like from colleagues with experience: the more discussion there is, the more likely it will be that clinicians will be able to make better decisions about devices for their patients, and understand how to make best use of them.

The site very much depends on your independent reviews and comments.

Reviews are easy to write and are based on the design and features of the equipment, what it’s like to use (i.e. does it do what the manufacturer says it does), comparisons with any similar equipment and a score out of 5. Members of the site can also post their own comments and images of equipment in use. As a device reviewer you must be an experienced user of the product. You will also need to declare ‘no conflict’.

Each review we publish also earns impact factor points. These points will increase your ranking in the community. If revenue permits we hope to reward those with the most points at the end of each year.

Remember your review will be read by an international audience of over 2,000 members and the site receives over 4,000 visitors a month! Please get in touch at info@whichmedicaldevice.com if you think you can contribute.

Ardian's catheter-based treatment for hypertension demonstrates blood pressure reduction

Thu, 18 Nov 2010 00:00:00 GMT

Findings reported at the American Heart Association Scientific Sessions 2010 and published in The Lancet yesterday demonstrated that the landmark Symplicity HTN-2 trial evaluating Ardian’s Symplicity® Catheter System™ met its primary endpoint.

The study showed that, after six months, patients treated with Ardian's device experienced an average drop in blood pressure of 32/12 mmHg compared to an increase in blood pressure of 1/0 mmHg in the control group of patients treated with medical therapy alone (p<0.0001).

Research has shown that each incremental 20/10 mmHg increase of blood pressure above normal levels is associated with a doubling of cardiovascular mortality over a 10 year periodⁱ and that reducing systolic blood pressure by as little as 5 mmHg can reduce the risk of stroke by almost 30 percent.ⁱⁱ

“The impressive results of this study show that Ardian’s Symplicity System has the potential to become a truly revolutionary treatment,” said Murray Esler, M.D., Ph.D., principal investigator of the trial and associate director of the Baker IDI Heart and Diabetes Institute of Melbourne, Australia. “Combined with findings from the earlier Symplicity HTN-1 study, which demonstrated the safety and durability of the therapy out to two years, these results fuel our enthusiasm for the potential of this treatment to significantly impact the standard of care for the large number of patients suffering from this disease.”

The Symplicity HTN-2 trial was an international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension. One hundred-six patients were enrolled from 24 investigational sites. At baseline the randomized treatment and control patients had similar high blood pressures: 178/97 mmHg and 178/98 mmHg, respectively, despite both receiving an average daily regimen of five antihypertensive medications. After six months, the average blood pressure of the renal denervation group was reduced to 146/85 mmHg, compared to an average blood pressure of 179/98 mmHg for the control group.

The study also found that the therapy was safe, with no serious device or procedure-related events, no cardiovascular complications and no kidney-related complications.

i Lewington S., et al. Lancet. 2002;360:1903-1913.
ii Mohr, J.P., Churchill Livingstone, 2004.
iii Mathers, C., et al. World Health Organization; 2009.

BSIR discuss off-label device use

Mon, 15 Nov 2010 00:00:00 GMT

This years BSIR (Liverpool UK) featured an interesting plenary session on ‘off label use of devices-is it legal?’

The speakers included:

Dr Susanne Ludgate giving the MHRA perspective
Mr Peter Merchant giving the legal perspective
Professor Duncan Ettles giving the radiologists perspective

Innovation often comes from the use of a device in an unusual scenario, perhaps a use for which the device was never intended. We’ve probably all done this at times, eg use of a Foley bladder catheter for a replacement gastrostomy tube, thrombin injection for pseudoaneurysms. The session heavily revolved around where we stand legally in using devices ‘off label’.

My understanding is that if a device is used ‘off-label’ and the patient comes to harm then the practitioner may not be prosecuted provided that it is accepted practice to use the device in that way by other clinicians. If it is deemed necessary to use a device ‘off label’ then it is advised that the following are undertaken:

1. A documented risk assessment is carried out.
2. Consider the ethical and legal implications
3. implement suitable precautions to minimise risk
4. Review the risk assessment at suitable periods
5. Inform the patient and gain their consent
6. Record the same in the patients notes
7. Ensure the patient is made aware of the risks
8. Any problems with the device/IFU should be reported to the MHRA (in UK)
9. Discuss the proposed use with colleagues to seek advice and inform the risk management team in the trust.
10. Record the use in the patients notes and the reasons for use.

Clearly all these actions cannot be undertaken in an emergency situation and that could pose problems. How many of use have taken these actions prior to the use of thrombin for treating pseudoaneurysms ? This technique was first published in 1986 and then was revived in the late 90s for femoral pseudoaneurysms. The alternatives to its use are surgery (potential risk) or compression, which is both time consuming and painful. The interesting thing here is that thrombin is not only unlicensed for this use, but its intravascular use is specifically contraindicated in the IFU. You could argue that a pseudoaneurysm is not truly intravascular. I and my colleagues were among the first to undertake this treatment and clearly at this stage in its evolution it was not established practice and if we had a complication we could well have been liable. However we would now have more colleagues to support us.

I am keen to get some discussion going on ‘off-label’ device use and have opened a topic in the forum. Please contribute your opinions.

Further information on this topic can be found at:

http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON065771

http://druganddevicelaw.blogspot.com/2009/04/off-label-use-and-medical-malpractice.html

http://www.mesotherapyworldwide.com/images/pdf/Amer_Journal_Mesogun.pdf

BMJ feature recommends tighter controls on devices, but is this really the way to go?

Fri, 05 Nov 2010 00:00:00 GMT

In this week’s British Medical Journal (6^th November 2010), an editorial and a feature article raise concerns about regulatory approvals for medical devices, particularly in relation to the FDA’s treatment of an implantable vagus nerve stimulator.

There are concerns that the regulatory traditions of the device world lag behind those of the pharmaceutical, and in particular that the present system allowing approval of devices on the basis that they are “substantially similar” to existing devices is not rigorous enough. Observers of the FDA will have noticed that approval to market a device for meniscal replacement in the knee (the Menaflex Collagen Scaffold) has recently been withdrawn after the realization that the device was in fact not as similar to preexisting (predicate) devices as had been thought – in particular it was intended to stimulate the growth of new tissue rather than replacing it

The leader by Jerry Avorn (Professor of Medicine at Harvard) in the BMJ complains that devices are not routinely held on a register, making post marketing surveillance difficult and points out interestingly that stents used for treating peripheral arterial disease were in fact only approved for the treatment of biliary duct stenosis.

The feature article by Jeanne Lenzer and Sharon Brownlee discusses the problems associated with the use of an implantable vagus nerve stimulator (VNS) manufactured by Cyberonics and used for the treatment of epilepsy not responding to drug treatment. Deaths have been reported amongst patients with the device, some of whom have had asystolic episodes which improved after the device was deactivated. The proposed solution includes a requirement for manufacturers to register adverse events and independent monitoring of outcomes.

Whilst the need to protect patients is important, it is to be hoped that the regulators avoid a response that makes it more difficult for new devices to get to market. The system for regulating drugs is not without its problems – clinical trials are expensive because of the underlying assumption that drugs should be absolutely safe and the trials process is prohibitively expensive. Many new pharmaceutical agents that could help patients never make it to market because of these economic and regulatory considerations. Getting the balance of risks right is tricky. Calling for tighter regulation is easy – doing what is really best for patients is not.

Top 10 Medical Innovations of 2011 - if you have deep pockets

Thu, 04 Nov 2010 00:00:00 GMT

It’s the time of year for top 10 lists. Here’s an interesting one from the staff of the US based Cleveland Clinic who have gazed into their crystal balls and nominated their pick of the top 10 medical innovations for 2011. The list includes early detection technologies for Alzheimer’s disease, a targeted T-cell antibody for melanoma and a cancer vaccine for metastatic prostate cancer.

The devices making the list include an implantable device for remote monitoring of cardiac functioning, the Trans-Oral Gastroplasty device (TOGA) for weight loss, and capsule endoscopy for the diagnosis of paediatric GI disorders.

Like any top 10 list, this list is subjective and reflects the perspective of the judges. It also has a high-tech North American feel to it. Elsewhere in the health care industry the idea of implementing low cost technologies from the developing world in the cash-strapped systems of the developed world is gaining traction. This “reverse innovation” has lead to the dissemination of ideas such as oral rehydration solutions for children with diarrhoea, the Aravind Eye Care System for low cost cataract surgery and a low cost ECG machine from GE, developed for emerging nations and now adopted globally. In these straitened times, 2011 could in fact be the year of “reverse innovation”. What do you think?

Annual Report of UK National Joint Registry supports back to basics approach

Mon, 18 Oct 2010 00:00:00 GMT

For those about to launch into using a new design of hip or knee replacement, the highlights of the seventh UK NJR report included:

Almost 1 million registered procedures.
65,000 primary hip replacements and 78,000 knee replacements registered in 2009
The number of cemented hip replacements has fallen significantly from 53% in 2004 to 36% in 2009.
The Exeter V40 stem and Contemporary socket are market leaders amongst cemented implants: the Corail stem and Pinnacle socket are market leaders in uncemented hip implants.
Revision rates were lowest for cemented hip replacements and highest for Metal-on-Metal hip resurfacings.
The number of hip resurfacings is falling (5,707 in 2008 to 4,099 in 2009), with the Birmingham Hip Resurfacing being the market leader, but the number of larger head bearings is increasing.
The PFC Sigma is the market leader amongst total condylar knee replacements.

The full report available at www.njrcentre.org.uk.

Which Interventional Device has become Which Medical Device.

Tue, 28 Sep 2010 00:00:00 GMT

We hope you like the new site and find it as easy, or even easier to use than the old site. We have now added cardiology and orthopaedics to the site and plan to increase the numbers of specialties covered in the near future. There are many devices and techniques that can be shared between specialties and we hope that we can all learn from this cross fertilisation of ideas.

As a registered member you can search device reviews, upload your own reviews, comments and images, view videos of devices in use and discuss complex cases with clinicians from around the world. Membership is open to clinicians and allied health care professionals.

We have an international panel of independent experts who write high quality reviews of the devices they use, but we are always looking for new contributors. Write a device review and earn points for your work. Your review will be available to over 4,000 visitors a month from around the world.

We are giving away an Apple iPad to the member who contributes the best original device review and an Apple iPod Nano to the most helpful comment on device use up to the end of November 2010 !

Outbreak of faith coincides with Pope's visit to Glasgow

Wed, 22 Sep 2010 00:00:00 GMT

The Smith & Nephew poster outside the Combined Orthopaedic Societies meeting in Glasgow raised a few smiles as the meeting coincided with the Papal visit to Scotland. The implication was that however the debate about metal on metal bearings went, and in reference to the faithful receiving the blessing of the Pontiff, you either believe or you don't.

The Smith & Newphew poster at COMOC 2010

Inside the meeting, it was interesting that despite podium presentations on the value of good evidence for orthopaedic practice, many of the exhibitors were showing devices without published results which might be seen as jostling for position in the gap in the market left by the flight from metal-on-metal bearings. These included large ceramic bearings and dual mobility hips, examples of the latter being made by Stryker, Biomet and Medacta. Another trend was the number of manufacturers showing knee replacements with customised jigs, such as the Biomet Signature and the Medacta Global knee system, claiming advantages including a smaller number of trays, and the benefits of navigation without a large machine in theatre.

DePuy ASR Hip System withdrawn from sale

Thu, 16 Sep 2010 00:00:00 GMT

A UK MDA alert issued on 7th September states that the DePuy ASR hip system has been withdrawn from the market. This follows reports of relatively poor results for the resurfacing system and should come as no surprise following earlier MDA alerts.

ASR sockets and resurfacing heads should be taken off the shelf and returned to the manufacturer. The MDA recommends that patients with implanted devices should be contacted and followed up.

Hip resurfacings and metal-on-metal bearings have been the subject of some controversy recently and it seems inevitable that the market share will decline. However, the decline in metal on metal bearing use has opened the way to other new unproven devices, with demand driven by direct to patient marketing. These include DePuy’s Delta Motion hip and Stryker’s “mobile bearing” ADM hip, both of which are said to provide advantages for younger patients. It remains to be seen whether these new devices catch on, or whether we see a return to more standard tried and tested devices.

CE mark approval for the RePort Guide Catheter System

Mon, 19 Jul 2010 00:00:00 GMT

Reverse Medical Corporation recently announced that it has received CE mark for its RePort Guide Catheter System, intended to provide intracranial access during interventional neurovascular procedures.

The RePort Guide Catheter System provides the neurovascular specialist with a new tool that can navigate deeply into the cerebral vascular anatomy, enabling them to treat more patients than with currently available technologies.

Reverse Medical scientific and clinical advisor Dr Satoshi Tateshima, UCLA Interventional Neuroradiology, Ronald Reagan UCLA Medical Center, Los Angeles, CA, stated, “The neurovascular anatomy often presents challenges related to fundamental access, and deep brain therapeutic microcatheter navigation support. The RePort Guide Catheter System design represents a game changing advancement over other guide catheters available today. The system is designed to be used across a broad range of neuro interventional procedures. It has also been designed to enable placement beyond the skull base more easily and safely than other currently available devices. I look forward to its US commercial availability in the future.”

The company plans to commence commercialisation during 2010.

Longer length GORE VIABAHN Endoprosthesis receives CE mark approval

Mon, 19 Jul 2010 00:00:00 GMT

The GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface has recently received CE mark approval. The new 25cm device is the longest length stent-graft available, designed to cover more of the lesion in the superficial femoral artery (SFA) potentially reducing the need for multiple devices.

The device features a precision laser trimming technology used to remove excess material, resulting in a contoured proximal edge that may improve flow dynamics at the proximal end. Removal of excess material at the proximal edge improves device apposition to the vessel wall when oversizing prevents device expansion to its nominal diameter. The device also incorporates the PROPATEN Bioactive Surface which utilises end-point immobilisation of derivatised heparin to the endoprosthesis luminal surface. This proprietary surface technology preserves the heparin bioactive sites such that they remain free to interact with the blood at the device surface without being consumed. The original GORE HEMOBAHN Endoprosthesis was introduced to Europe in 1996; the GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface was first approved for use in the EU in December 2008.

“In 1996, the [GORE] HEMOBAHN-VIABAHN device was the first SFA stent-graft that had good patency rates and it came already in 15cm length,” said Dr Jacques Bleyn, Antwerp Blood-Vessel Center, Antwerp, Belgium. “Because long SFA occlusions can be treated endovascularly with the GORE VIABAHN device, Gore took this best SFA device and made it better: heparin bonded and a new length of 25cm.”

The device is available with a low-profile delivery system that gives interventionalists a more streamlined approach to re-line the peripheral arteries. It is constructed with a durable, reinforced, biocompatible, ePTFE liner attached to an external nitinol stent structure. The excellent flexibility of the endoprosthesis enables it to better traverse tortuous areas of the SFA and conform more closely to the complex anatomy of the artery.

Longer balloons provide physicians more options for treating peripheral artery disease

Mon, 19 Jul 2010 00:00:00 GMT

Boston Scientific has announced that 22 new balloon sizes have been added to the PolarCath Peripheral Dilatation System, including balloon lengths of 120 and 150mm.

The new PolarCath balloons are available in both 0.014-inch and 0.035-inch guidewire-compatible platforms. The PolarCath System also offers balloon lengths of 20, 40, 60, 80 and 100mm.

"The expanded portfolio of PolarCath balloons will enable interventionalists to address longer lesions in the femoral and subfemoral arteries, often more efficiently than using several shorter balloons,” said Dr Tony S Das, Director of Peripheral Vascular Interventions at the Presbyterian Heart Institute, Dallas, US. “The PolarCath System also offers the potential benefits of CryoPlasty Therapy for these complex lesions.”

Pathway Medical Technologies receives FDA clearance for JETSTREAM atherectomy system

Mon, 19 Jul 2010 00:00:00 GMT

The FDA has granted the Pathway Medical Technologies 510(k) clearance to market JETSTREAM G3 SF (Small Fixed), the newest version of its peripheral revascularisation catheter for the treatment of peripheral vascular disease (PVD). The smaller size, fixed cutter and longer catheter length make JETSTREAM G3 SF an ideal option for treating blockages below-the-knee (BTK). JETSTREAM G3 SF allows physicians to treat a broader range of PVD patients, including the greater number of patients with critical limb ischaemia (CLI) and diabetes in the BTK population.

“The JETSTREAM G3 SF gives me a new tool in my arsenal to treat a wide range of PVD patients, including those with blockages in smaller arteries below the knee,” said Dr Malcolm T Foster III, research director at East Tennessee Heart Consultants and physician at Mercy Medical Center West, Knoxville, US. “In particular, patients with diabetes have often faced the threat of amputation due to poor circulation in the extremities. With JETSTREAM, some of these patients now have a viable option for treating CLI and saving their limb.”

According to the company, JETSTREAM G3 SF is the only below-the-knee device on the market that offers active aspiration. It is optimised for below-the-knee blockages and features a smaller, fixed cutter designed for enhanced performance in tortuousity and better navigation of the device through arteries of the lower leg.

Pre-market approval submission for the Zilver PTX Drug-Eluting Stent Platform

Mon, 19 Jul 2010 00:00:00 GMT

Cook Medical has submitted its Pre-Market Approval (PMA) application to the FDA for the company's polymer-free Zilver PTX Drug-Eluting Peripheral Stent. Intended for use in patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA), is a self-expanding, highly durable nitinol stent that uses a proprietary, polymer-free technology to deliver a locally therapeutic dose of paclitaxel, an antiproliferative drug, to the target lesion.

Cook's PMA submission includes data from the randomised portion of the ongoing Zilver PTX clinical trial, the largest study of its kind for the endovascular treatment of PAD in the superficial femoral artery (SFA).

Study update

Encompassing a global single arm registry and a randomised study involving 1,276 total patients including diabetics, symptomatic patients and those with complex lesions, the 479 patients enrolled in the randomised study and the 787 in the single arm study are experiencing clinical improvement, excellent stent durability (i.e., fracture resistance), high rates of event-free survival and freedom from target lesion revascularisation. Patency data from the single-arm study was reported at 86.2% at 12 months at EuroPCR in June.

Subclavian access feasible and safe with transcatheter device

Mon, 19 Jul 2010 00:00:00 GMT

In patients undergoing transcatheter aortic valve implantation (TAVI), subclavian access may be feasible for those with anatomical or disease characteristics that discourage the standard femoral approach. The new technique appears to be associated with high rates of procedural success and few in-hospital complications, reports a study published online July 6, 2010, ahead of print in Circulation: Cardiovascular Interventions.

Study design

Researchers led by Dr Anna Sonia Petronio, University of Pisa (Pisa, Italy), and colleagues looked at 514 consecutive patients who underwent TAVI using the CoreValve device (Medtronic) from June 2007 to July 2009 at 13 Italian hospitals. Among this cohort, 54 were treated with the subclavian approach at ten of the participating centres (mean of 5.4 patients treated per hospital). The majority of patients (n = 460) underwent femoral access.

According to the researchers, surgical risk was high in the overall study population, as evidenced by the mean logistic EuroSCORE of 20.1. Patients in the subclavian group had higher mean EuroSCORE and higher rates of comorbidities including PAD, CAD, carotid artery stenosis, prior MI, and prior PCI than those in the femoral group. However, subclavian patients were less likely to be New York Heart Association (NYHA) Class III/IV.

Clinical follow-up was obtained for a median of 6.9 months. At 30 days and six months, adverse event rates did not differ between the groups. Mortality was similar with subclavian and femoral access through six months. MACCE rates were primarily driven by mortality; stroke was almost always fatal while MI and reintervention were rare. Major bleeding and valve-related events occurred at equal rates regardless of access route.

Overall, improvement in NYHA functional class was “remarkable”, the researchers comment. At 30 days, 82% of the femoral group and 77.8% of the subclavian group showed at least a 1-class increase. This improvement was sustained at six months in 80.9% and 78.1% of patients, respectively.

Based on their findings, “vascular access through the subclavian artery can be considered a valid strategy in patients with contraindications to the femoral approach, allowing for enlargement of the eligibility for TAVI with the CoreValve,” Petronio and colleagues concluded.

New research reveals Genous Bio-engineered R stent is safe and effective in combination with drug-eluting balloon

Mon, 19 Jul 2010 00:00:00 GMT

Six-month clinical follow-up data presented at the World Congress of Cardiology Scientific Sessions 2010 in June, showed the safety and efficacy of the combination of pre-dilatation with a paclitaxel drug-eluting balloon (Sequent Please, B.Braun) followed by implantation of the Genous Bio-engineered R stent (OrbusNeich) for the percutaneous treatment of coronary artery stenosis.

Study design

In the investigator-initiated, single centre, all-comers POTENT (Paclitaxel-eluting ballOon and bio-engineered progeniTor cEll-attracting stainless steel steNT in percutaneous treatment of coronary artery stenosis) registry, 32% of patients were diabetic, 86% were male, 58% had a previous myocardial infarction and the mean age of the study population was 56 years. Of the lesions treated, 46% were type B2/C lesions. The patients received a pre-loading of dual antiplatelet therapy (DAPT) at least six hours prior to the percutaneous coronary intervention, and the DAPT was continued for three months. There were no in-hospital or 30 day major adverse cardiac events (MACE) reported. There was one case of late stent thrombosis.

In the six-month clinical follow-up of the 50 patients in the study, the MACE rate was 6%, and the clinical driven target lesion revascularisation (TLR) rate was 4%. In an optional nine-month angiographic follow-up of 35 patients, no patients exhibited binary restenosis.

“We are very encouraged by the low MACE and binary restenosis rates, which are comparable to other stenting strategies and demonstrate the potential for combining drug-eluting and pro-healing technologies,” said Dr Tiong-Kiam Ong, Sarawak General Hospital, Malaysia, and principal investigator of the study. “This therapeutic strategy could be a potent remedy for the dual problem of in-stent restenosis and stent thrombosis.”

Study shows treatment with SES in CTOs results in less restenosis compared with BMS

Mon, 19 Jul 2010 00:00:00 GMT

Latest study results have shown that in chronic total occlusions (CTOs), treatment with sirolimus-eluting stents (SES) leads to less restenosis at eight months compared with bare-metal stents (BMS). Patients who receive SES also require less repeat revascularisation at two-year follow-up, according to randomised clinical trial data published online June 20, 2010, ahead of print in the European Heart Journal.

For the GISSOC II-GISE trial, researchers led by Dr Paolo Rubartelli, Ospedale Villa Scassi (Genoa, Italy), enrolled 152 patients at 13 Italian centres between May 2005 and September 2007. Patients, who all had de novo CTOs present for at least 30 days in a native coronary artery, were randomised to receive SES (n=74; Cypher, Cordis/Johnson & Johnson, Miami Lakes, FL) or BMS (n=78; Bx Sonic, Cordis). Angiographic follow-up was performed at eight months, and clinical follow-up was conducted through 24 months.

Eight-month restenosis favours SES

Angiographic follow-up was obtained at a mean of 8.4 months in 84% of the cohort. The primary endpoint of in-segment minimal lumen diameter was larger with SES treatment, which also produced less in-segment late lumen loss and binary restenosis. Total reocclusion occurred in 16.9% of BMS patients but in none of the SES patients (P = 0.001).

At 24-month follow-up, SES and BMS patients had similar rates of most clinical outcomes. The rate of MACE (defined as death, MI, emergent CABG, TLR, or TVR) was lower with SES treatment, driven mainly by a reduced need for repeat revascularisation. Angina and silent ischaemia were also less common in SES patients.

CoreValve System shows long-term efficacy and durability in pivotal trial

Fri, 04 Jun 2010 00:00:00 GMT

New clinical data presented at the recent EuroPCR held in Paris (May) demonstrated positive long-term performance and durability for the CoreValve transcatheter aortic valve replacement system from Medtronic.

The system, designed to replace a diseased aortic valve without open-heart surgery or surgical removal of the native valve, has now been implanted in more than 10,000 patients worldwide in 32 countries outside the US. Typically delivered through the femoral artery, CoreValve is used in 75% of transarterial transcatheter valve replacement procedures.

“These pivotal trial results provide important evidence and confidence to physicians that CoreValve is an effective long-term treatment alternative for many patients with severe aortic stenosis who are considered at high surgical risk or inoperable,” said Dr Ulrich Gerckens, HELIOS Heart Center Siegburg, Siegburg, Germany. “Without valve treatment this patient population faces a 50% chance of survival from cardiovascular events at two years. In contrast, patients who received CoreValve have a greater chance of survival and overall better heart function.”

The study evaluated 126 patients at nine centres in Europe and Canada who were implanted with the currently marketed 18F CoreValve system. Investigators reported the following study results:

Two-year effectiveness data: About three quarters (73%) of patients saw their heart failure symptoms improve substantially (one or more NYHA class improvement). Valve opening area increased 2.5 times from baseline on average and remained stable at two years. Resistance to forward flow through the valve (peak and mean valve gradient) was decreased by 75 to 80%.
Two-year survival data: Two-year cardiac survival was 74%.
Two-year valve performance: Over two years, no valve migrations or valve deterioration occurred.

The CoreValve system received CE mark in March 2007. It is not yet available in the US for clinical trial or commercial sale or use.

Sterling SL Balloon Catheter is launched in US and Europe

Fri, 04 Jun 2010 00:00:00 GMT

Boston Scientific announced the US and European launches of the Sterling SL PTA balloon dilatation catheter, a high-performance balloon dilatation catheter designed for use in peripheral angioplasty procedures below-the-knee. The company plans to launch the product immediately in both markets.

The Sterling catheter provides a low tip profile, deliverability and rapid deflation time. “The introduction of the Sterling SL Balloon Catheter will provide the length options I need to address below-the-knee procedures for patients with peripheral artery disease,” said Dr Kenneth Kollmeyer, DFW Vascular Group and Chief of Vascular Surgery, Methodist Dallas Medical Center, US.

First US implant of RENEW, interspinous allograft technology for treatment of lumbar spinal stenosis

Fri, 04 Jun 2010 00:00:00 GMT

The first commercial implant recently took place in the US of the RENEW Interspinous Allograft Technology (Interventional Spine) for the treatment of lumbar spinal stenosis (LSS).

The RENEW Implant is an interspinous process device made from allograft for the treatment of lumbar spinal stenosis. Designed for ease of implant and to provide a more ‘natural’ interference within the spinous process, the company believes that this innovative device will improve outcomes and provide cost efficiencies to hospitals and surgeons.

The implant is available in six different sizes to accommodate the patient’s anatomy.
The first implant was performed at the Inova Fairfax Hospital in Fairfax, Virginia, by Dr Ronald C Childs. Upon completing the procedure, Childs commented: “I am very pleased with this product. The use of the RENEW implant provides, in my view, a welcomed alternative to the other various interspinous process devices made from synthetic materials presently in the market.”

iVAS Inflatable Vertebral Augmentation System is launched

Fri, 04 Jun 2010 00:00:00 GMT

Stryker's Interventional Spine business unit announced the release of its iVAS inflatable vertebral augmentation system, a minimally invasive device cleared for use in treating vertebral compression fractures (VCFs).

The device is part of a range of mixer and delivery systems, bone cements and needles for both vertebral augmentation (balloon kyphoplasty) and vertebroplasty.

iVAS is designed with five key features that help promote enhanced procedure efficiency and outcomes:

The stiff distal balloon catheter provides rigidity for smooth insertion.
A flexible proximal catheter allows for easy maneuverability.
The radiopaque markers on the balloon catheter helps facilitate accurate visualisation and placement of the balloon.
The hand drill cuts cleanly through cancellous bone to create a channel for balloon placement.
Graduation markings on the access cannula assist in measuring needle depth.

First implants of TX2 thoracic endograft completed

Thu, 03 Jun 2010 00:00:00 GMT

The completion of the first implants of the Zenith TX2 Low Profile TAA Endovascular Graft (Cook Medical) took place in May 2010, as part of a clinical investigation, by assistant Professor Piotr Kasprzak, head of vascular surgery at the University Hospital Regensburg, Germany.

At 16F or 18F, the TX2 Low Profile delivery system is smaller than a standard TX2 device and is engineered to allow patients with challenging anatomies to be treated percutaneously. As a result, patients who previously may not have been suited to thoracic endovascular repair, for example those with narrowed, small or tortuous arteries, may now benefit from minimally invasive treatment.

Up to ten medical centres across Europe may take part in the TX2 Low Profile TAA study. Kasprzak said: “Treating an aneurysm with the TX2 Low Profile TAA from Cook Medical shows great promise. With this stent we’re able to treat patients with TEVAR. The TX2 Low Profile may provide a viable alternative to open surgery that may result in lower risks of complications to a larger patient population.”

VIBE RX: New vascular imaging balloon catheter

Thu, 03 Jun 2010 00:00:00 GMT

Volcano Corporation has received CE mark approval for the VIBE RX Vascular Imaging Balloon Catheter. The company also announced that it has completed its first clinical cases with the VIBE RX in New Zealand. A single VIBE RX Catheter can quickly access, prepare, and assess challenging lesions. IVUS guidance provides precise, targeted balloon dilatation with immediate confirmation of interventional results.

According to Dr John Ormiston, Medical Director at Mercy Angiography in Auckland, New Zealand, “Volcano has successfully combined two important interventional tools – IVUS and balloon dilatation into one powerful device. “Physicians will have an attractive alternative to using separate IVUS and balloon dilatation catheters in a procedure. The use of imaging for more precise lesion assessment and stent placement has certainly benefited my patients. Integrating imaging directly onto the therapy device removes another barrier to IVUS use.”

New indication for complete self-expanding stent receives FDA approval

Thu, 03 Jun 2010 00:00:00 GMT

Medtronic announced in April 2010 that it has received approval from the FDA for the Complete SE Vascular Stent System to be used for the treatment of peripheral arterial disease (PAD) in the iliac arteries.

The Complete SE Vascular Stent System features several novel advances, including an innovative dual-deployment delivery system with a unique triaxial design. The new delivery system is made up of an inner shaft, a retractable sheath and a stabilising sheath that reduces friction and allows the retractable sheath to move back freely. This decreases the amount of force required to deploy the stent, thereby making deployment easy and precise.

Closure device uses single suture, steel ring

Thu, 03 Jun 2010 00:00:00 GMT

The Quick-Close Vascular Suturing System from Interventional Therapies LLC received FDA clearance in April 2010. It consists of the Quick-Close Suture Applier and the Quick-Ti Cinch Applier. The suture applier has a pistol grip shape and contains a single strand of an artificial suture (polybutester Novafil) fitted with stainless steel rings.

The suture applier is used to gain access to the puncture site. Using manual control, and relying on the sense of touch, the device is used to place one end of the suture through one edge of the arterial wound. The suture applier is then repositioned and the other end of the suture is inserted through the opposite edge of the wound site. As the suture applier is withdrawn from the wound, a 24-inch length of suture is forced out of its housing. The suture applier places a single stitch of a non-absorbable, single thread suture to the wound site. The cinch applier gathers the two ends of the suture and then it places a stainless steel ring that acts in place of a knot to secure the suture in a closed position to stop the bleeding.

It is designed for use in vascular punctures with diameters of 4mm or larger.

Mynx M5: Designed specifically for 5F closure

Tue, 01 Jun 2010 00:00:00 GMT

AccessClosure has introduced its newest addition to the Mynx family, the Mynx M5 vascular closure device. Designed specifically for 5F closure, the Mynx M5 delivers an extravascular, conformable sealant through the existing 5F procedural sheath, eliminating the need for a sheath exchange and preserving the size of the arteriotomy. In addition, the Mynx M5 provides all the same benefits as the 6/7F Mynx. The device is deployed gently, avoiding cinching and tugging of the artery. Without the use of a suture or permanent metal implant, the Mynx sealant is placed on the surface of the artery.

According to the company, it immediately seals both the arteriotomy and the tissue tract, rapidly absorbing blood and subcutaneous fluids and minimising ooze. The Mynx sealant then dissolves completely through hydrolysis within 30 days. Furthermore, the company explains that the Mynx design minimises the discomfort commonly associated with vascular closure due to its deployment method and sealant material. It also uses a soft, bioabsorbable polymer sealant material, polyethylene glycol.

The Mynx Study
The Mynx study was a prospective, multi-centre, non-randomised clinical investigation conducted at five European centres. Patient enrollment included 190 patients with 50% of patients having undergone diagnostic catheterisation and 50% interventional procedures.

The primary safety endpoint was the combined rate of major complications within 30 days. The primary efficacy endpoints were time to haemostasis and time to ambulation.

Key results from the Mynx Study:

0.5% rate of major complications
Absence of complications requiring surgical repair
Rapid haemostasis (mean 1.3 minutes) independent of anticoagulation
Time to haemostasis comparable whether the patient underwent a diagnostic (median 0.5 minutes) or interventional (median 0.6 minutes) procedure
Consistently rapid time to ambulation of 2.0 hours for diagnostic patients and 1.9 hours for interventional patients

Mynx Study conclusions:

Demonstrated safety and efficacy
Extravascular, water-soluble sealant offering unique safety profile
Rapidly resorbs, leaving nothing behind
Potential for clinical versatility – PVD, immediate restick, obesity

Mynx M5 One Hour Ambulation Study
Commencing in March 2010, the Mynx M5 One Hour Ambulation Study (official title: ‘Single-centre, Post Market, Prospective, Consecutive, Single-arm Study Compared to Historical Control [Diagnostic Arm of the Mynx 6/7F Study]’), will assess the safety and tolerability of participants ambulating within one hour of placement of the Mynx M5 closure device. Participants will be assessed for adverse event occurrence for 30 days. The study is expected to be completed in August 2010.

INNOVATION trial: First patients enrolled in study of new stent graft system to treat AAA

Tue, 01 Jun 2010 00:00:00 GMT

The first patients have been enrolled in the INNOVATION trial, which will assess the safety and performance of a new stent graft system, the Incraft (Cordis), to treat abdominal aortic aneurysm (AAA).

The Incraft’s delivery system features a low-profile that is made possible by using an integrated sheath of braided construction. The outer diameter of the integrated delivery system, which includes the device and sheath is 14F, whereas currently available endovascular aneurysm repair (EVAR) devices have system profiles ranging from 18 to 24 F.

The INNOVATION trial is a multi-centre, open-label, prospective, non-randomised study assessing the Incraft system in subjects with AAA. It will enrol up to 25 patients in three sites throughout Germany.

According to trial investigator Professor Giovanni Torsello, Chief of Vascular Surgery at St Franziskus Hospital, Muenster, “I am pleased to be a part of the INNOVATION trial. The ability to customise the Incraft system during the procedure is a very helpful feature for clinicians.”

The initial procedures using the system were performed by principal investigator Professor Dierk Scheinert, head of the Department of Medicine, Angiology and Cardiology at Park-Krankenhaus Hospital in Leipzig. Scheinert commented, “We have been excluding a significant portion of our AAA patients, especially women, from EVAR because current stent grafts have large and bulky delivery systems, making device introduction impossible for small or diseased access vessels. The ultra-low profile delivery system of Incraft will make EVAR a possible treatment alternative for a wider range of patients.”

New trial results on ExoSeal support its clinical safety and efficacy

Tue, 01 Jun 2010 00:00:00 GMT

The new ExoSeal vascular closure device (Cordis) received CE mark in May 2010 and was recently launched at the EuroPCR meeting in Paris. The company states that it incorporates a number of new advances in technology and simplicity of design to provide precise and secure extravascular arterial closure. The new product was shown in a recent clinical trial to have an “excellent” clinical safety profile (in terms of vessel injury, access site-related bleeding, infection or nerve injury, new ipsilateral lower extremity ischaemia or serious adverse events [SAE]) during vascular procedures.

The ExoSeal device makes use of key technological developments to support the clinical safety of the closure procedure. The bioabsorbable polyglycolic acid (PGA)-plug, is fully reabsorbed in 60–90 days. According to Cordis, a system of deployment through the existing procedural sheath makes ExoSeal quicker and easier to use and increases physician convenience by minimising or eliminating the need for sheath exchange during the procedure. The device uses visual indicators to help the clinician deploy the device correctly. This ‘visual feedback’ also promotes patient comfort during deployment and the 'lock-out' system of ExoSeal helps ensure that only extra-vascular plug placement can take place.

ECLIPSE Trial

The safety and effectiveness of the ExoSeal was assessed in two non-randomised studies conducted in Mexico and Germany, as well as a study in the US where the 6F ExoSeal was compared with manual compression (MC) with a 2:1 randomisation in patients undergoing diagnostic and interventional coronary/peripheral procedures. The trials tested the time to haemostasis, the time to ambulation and the 30-day combined rate of access site-related complications. The results showed that there were no major adverse events, no vascular repair, no access site-related bleeding requiring transfusion, no access site-related infection requiring treatment, no new ipsilateral low extremity ischaemia and no surgery for access site-related nerve injury.

The trial recorded no adverse clinical events and achieved a level of safety comparable to manual compression while significantly reducing time to ambulation. The device has achieved this level of clinical safety by combining easy-to-use functionality with trusted bioabsorbable technology and precise extravascular closure.

ARMOUR study: MO.MA device is safe and effective for patients at high surgical risk for CEA who undergo CAS

Tue, 27 Apr 2010 00:00:00 GMT

New research presented at the recent Society of Interventional Radiology (SIR) Meeting in Tampa, Fl, revealed that use of a new cerebral protection device in combination with carotid stents in high surgical risk patients provides a minimally invasive, safe and effective way to prevent stroke from occurring.

The MO.MA proximal embolic cerebral protection device (Invatec) acts as a balloon occlusion ‘endovascular clamping’ system to achieve cerebral protection prior to crossing the carotid stenosis. The device consists of a catheter with two compliant balloons at its distal portion, which can be independently inflated and deflated. A central lumen allows advancement and usage of the interventional devices (PTA balloons and carotid stents). The MO.MA device effectively reduces and captures debris released during the stenting procedure to prevent it from travelling to the brain, where it has the potential to cause a stroke. It is designed to achieve cerebral protection by proximal blood flow blockage at the carotid bifurcation: antegrade and retrograde flow blockage are achieved by proximal balloon occlusion of the common carotid artery (CCA) and distal balloon occlusion of the external carotid artery (ECA), respectively. Cerebral protection is thus established prior to the initial wire passage through the stenosis and maintained during the entire procedure. The MO.MA provides withdrawal of embolic particles by allowing manual syringe aspiration of any micro-emboli at the end of the procedure before restoring blood flow through the stented vessel.

ARMOUR clinical trial results

The results of the pivotal, multi-centre, non-randomised ARMOUR trial demonstrated the safety and effectiveness of MO.MA proximal flow blockage cerebral protection device for patients at high surgical risk for carotid endarterectomy (CEA) undergoing carotid artery stenting (CAS). In the prospective study, 262 patients were enrolled at 25 investigational sites in the US (20) and the EU (5) between September 2007 and February 2009. All study participants underwent percutaneous revascularisation of the carotid artery using the MO.MA device and a stent approved by the FDA for carotid artery stenting.

Primary outcome measures were major adverse cardiac and cerebrovascular events (MACCE) within 30 days of implantation. Secondary outcome measures were device success, technical success, procedural success, restenosis at 30 days, and target lesion revascularisation (TLR) at 30 days.

For the intention to treat population (n=225), the mean age was 74.7 years with 66.7% of the cohort being male. Symptomatic patients comprised 15.1% and 28.9% were octogenarians, and device success was 98.2% and procedural success was 93.2%. The 30-day MACCE rate was 2.7% [95% CI (1.0-5.8%)] with a 30-day major stroke rate of 0.9%. The mortality rate was 0.9%, and there were no myocardial infarctions. The device success for the MO.MA was 98.2%, technical success 94.6%, and procedural success 93.2%. The access site complication rate was 3.1%.

The trial investigators stated that the absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated prospective multi-centre registry trial to date.

Dr L Nelson Hopkins, State University of New York, Buffalo, US, and co-principal investigator of the ARMOUR trial stated, “Proximal embolic protection is an important advance that gives us more options in the treatment of carotid artery disease. The MO.MA Ultra combines the advantages of carotid endarterectomy with the minimally invasive benefits of carotid artery stenting.”

He added that, contrary to popular opinion, the device is easy-to-use, device intolerance is rare and usually reversible and, as confirmed by magnetic resonance and transcranial Doppler imaging, less emboli travel to the brain. Hopkins said that it appears as if proximal embolic protection may be the procedure of choice for recently symptomatic patients, low gray-scale measure lesions, and perilesional tortuosity. This technology may also prove useful for string sign lesions, acute carotid occlusion/stroke, and luminal thrombus in the future.

“These results confirm the safety and effectiveness of the MO.MA device for proximal protection in high surgical-risk patients, and the cumulative event rate compares very well with the other trials,” he concluded. “I like to think of this as an endovascular endarterectomy. The procedure shuts down all the vessels, removes or pushes aside the plaque, and then aspirates out all the debris, much like we do with an endarterectomy. As a result, we have the advantages of the endarterectomy combined with the benefits of a minimally invasive procedure and short occlusion times for the patient.”

ACT I Study

Tue, 27 Apr 2010 00:00:00 GMT

ACT I is comparing CAS with CEA for the treatment of asymptomatic extracranial carotid atherosclerotic disease. The study is being conducted to demonstrate the non-inferiority of CAS using the Emboshield Embolic Protection System and Emboshield Pro Embolic Protection System (Abbott Vascular) with the Xact-Carotid Stent System to CEA. An update was recently presented at the recent LINC meeting (Leipzig, Germany) by Dr John Laird, Davis, US.

The planned recruitment is 1,858 who will be randomised to a ratio of 3:1 (CAS: CEA). Patients are followed at 24 hours, 30 days, six months and annually up to five years post procedure. A neurological exam performed by an independent neurologist/neurosurgeon or NIHSS certified specialist at pre-enrolment, 24-hours and 30-days post-procedure, six-months and annually up to five years. To date, a total of 980 patients have been randomised.

The primary endpoint is composite death, stroke, myocardial infarction (MI) at 30 days post-procedure, plus ipsilateral stroke from 31 to365 days post-procedure. Secondary endpoints include death and ipsilateral stroke (years two-five years), cranial nerve injury, bleeding, vascular and/or wound complications requiring treatment, complications of general anaesthesia, access artery, renal and airway complications, freedom from clinically-indicated target lesion revascularisation
(TLR) at six and 12 months, acute stent success (residual stenosis <50% by QCA covering an area no longer than original lesion), acute filter success (successful deployment and retrieval of filter in absence of angiographic distal embolization and procedural success (residual stenosis <50% by QCA and freedom from major adverse event at 30 days).

Laird explained, “My prediction from the outcomes of ACT 1 would be low event rates in both groups, with no significant difference between CAS and CEA. This will be due to the use of experienced operators, a lower risk patient group, utilising newer generation devices. However, despite the low event rates, the trial will not convince neurologists that CAS or CEA is indicated for asymptomatic
carotid artery stenosis.”

ICCS: Interim results show surgery is preferable to stenting

Tue, 27 Apr 2010 00:00:00 GMT

An interim safety analysis of the ongoing International Carotid Stenting Study (ICSS) offers strong evidence that carotid endarterectomy (CEA) is preferable to carotid stenting (CAS). ICSS investigators assessed the effectiveness of stenting and endarterectomy at preventing stroke, death, and procedure-related heart attacks in 1,713 patients with recently symptomatic carotid stenosis. Patients were randomly assigned to stenting (n=855) or surgery (n=858) and followed for up to 120 days after randomisation.

Findings showed that patients in the stent group had a significantly greater risk of stroke, death, or procedure-related heart attack within 120 days of randomisation –absolute risk 8.5% compared with 5.2% in the surgery group. Additionally, within 30 days of treatment the rate of stroke or death in the stent group was nearly twice the rate recorded in the surgery group. According to the authors, this difference was mainly due to a higher number of non-disabling strokes recorded in the stent group (36 versus 11 within 30 days of treatment), whereas the number of disabling strokes or deaths did not differ significantly (26 versus 18).

The authors concluded that, “Completion of long-term follow-up is needed to establish the efficacy of treatment with a carotid artery stent compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for symptomatic patients suitable for surgery.”

SPACE and EVA-3S: CAS fails to meet criteria for non-inferiority in comparison with CEA

Tue, 27 Apr 2010 00:00:00 GMT

Results from the Stent-Supported Percutaneous Angioplasty of the Carotid Artery vs Endarterectomy (SPACE) trial and the Endarterectomy vs Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S), showed that carotid stenting failed to meet criteria for non-inferiority versus endarterectomy, and showed slightly higher rates of ipsilateral ischaemic stroke and death at 30 days.

However, longer-term follow-up of both trials, presented at last year's European Stroke Conference (2009), showed rates of ipsilateral stroke were low and similar between carotid stenting and endarterectomy groups at two and four years of follow-up.

According to SPACE investigator Dr Peter A Ringleb, rom Ruprecht-Karls-University, Heidelberg, Germany, “The conclusion from the SPACE trial is exactly the same as the EVA-3S study; that is, if a patient has been treated successfully without any complications, the [long-term] risk of a secondary stroke is very small and very comparable between these two modalities.”

SPACE Trial

The SPACE trial was a multi-national, prospective randomised study that aimed to test the hypothesis that CAS was not inferior to CEA for the treatment of patients with severe symptomatic carotid stenosis of >70%. A total of 1,214 patients were randomised to carotid angioplasty with stenting (n=613) or CEA (n=601). Thirty-day results from this trial did not prove non-inferiority of CAS compared with CEA.

Two-year results showed that in both intention-to-treat (ITT) and per-protocol analyses, Kaplan-Meier estimates of ipsilateral ischaemic stroke up to two years after the procedure and any periprocedural stroke or death were similar between the groups.

It was reported that restenosis of 70% or greater was significantly more common in the stenting group, again in both ITT and per-protocol analyses. However, only two cases of restenosis were associated with neurological symptoms, the authors noted. Although the incidence of restenosis was higher, they add, “it cannot be excluded that the degree of in-stent stenosis is slightly overestimated by conventional ultrasound criteria.”

The authors concluded, “Patients who were successfully treated with stent-protected angioplasty had a similar low risk of secondary cerebrovascular events as patients who were treated with endarterectomy, indicative of the similar preventive ability of endarterectomy and carotid angioplasty with stenting.” They added, “To assess the long-term effects, and particularly the effect of restenosis, most investigators agreed to collect follow-up data for up to five years after the initial study protocol had ended.”

EVA-3S

The EVA-3S trial was also a randomised non-inferiority trial comparing CAS with CEA in 527 patients with carotid stenosis of 60% or more that had recently become symptomatic. The trial was stopped early due to a higher risk of any stroke or death within 30 days of the procedure, and the main results published within a week of those of the SPACE trial in 2006.

In a recent paper, the EVA-3S investigators, with lead author Dr Jean-Louis Mas, HÃ´pital Sainte-Anne, Paris, France, reported on follow-up of these patients out to four years. They found that the cumulative probability of periprocedural stroke or death and non-procedural ipsilateral stroke was still higher among those in the stenting group versus endarterectomy.

However, the authors explained that a hazard function analysis showed that the differences in cumulative outcomes between stenting and endarterectomy were largely accounted for by events that occurred within 30 days of the original procedure. They explained, “After the periprocedural period, the risk of ipsilateral stroke was low and similar in both treatment groups.”

To conclude, the authors stated, “The safety of carotid stenting needs to be improved before it can become a widespread alternative to carotid endarterectomy in patients with symptomatic carotid stenosis.”

Initial experience with innovative new stent delivery system

Tue, 27 Apr 2010 00:00:00 GMT

Recently, the Department of Angiology at the Park Hospital, Leipzig, participated in the initial release of the SUPERA VERITAS Peripheral Vascular Stent delivery system. Compared to previous generations of SUPERA stent delivery systems, they experienced significant improvements and found that SUPERA VERITAS provides the operator with a smooth and controlled deployment of the SUPERA stent. The system also incorporates ease of use by significantly reducing the number of steps needed to prep and deliver the stent.

According to Dr Dierk Scheinert, Leipzig, Germany, “In our department we have been utilising the SUPERA stent clinically for over two years and we have been very impressed with the performance of the stent and positive clinical outcomes. Even in the most challenging anatomy, the SUPERA stent has delivered the strength and flexibility to accommodate the most challenging vessels in the femoropopliteal region. The interwoven nitinol stent is truly a differentiated platform that produces best in class radial strength without sacrificing flexibility or durability. In our experience we have learned that this differentiated platform requires different vessel preparation and sizing considerations compared to using ‘slotted tube’ stents.”

He further explained that it is important to prepare the vessel to the outer diameter of the stent and size the outer diameter of the stent 1:1 to the vessel. Due to the increased radial strength of SUPERA, there is no need to oversize the stent and doing so will actually compromise the performance and accuracy of the stent.

There are several ongoing studies to evaluate the clinical performance of SUPERA including the Leipzig Registry at Park Hospital and the SUPERB clinical trial.
In the Leipzig Registry, the researchers have follow-up on 107 patients with lesions in the superficial femoral artery (SFA) and 76 patients with popliteal obstructions treated with the SUPERA stent. The initial data shows high patency rates of >85% at 12 months in both locations and no fractures even in the popliteal segment.

“This is very exciting and I believe that this could be a ‘game changing’ technology for stenting in the peripheral space,” explained Scheinert.

The SUPERB (Comparison of the SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery) trial is a prospective, single-arm trial of 258 patients at up to 38 U. sites and two European sites. The objective of the trial is to demonstrate the safety and effectiveness of the SUPERA stent in the treatment of obstructive arterial disease in the superficial femoral artery of the lower extremity. This trial is currently enrolling patients.

In conclusion, Scheinert believes that the SUPERA VERITAS delivery system is much improved and provides smooth and easy delivery of the SUPERA stent. The SUPERA stent has proven to be a significant advancement in stent technology and its unique characteristics allow physicians to treat areas where standard ‘slotted tube’ nitinol stents have always encountered difficulty.

EVAR, DREAM, ACE and OVER trial updates

Tue, 27 Apr 2010 00:00:00 GMT

At the recent LINC meeting, Leipzig, Germany, Louise Brown presented an overview of the results from several endovascular aneurysm repair (EVAR) versus open repair trials in fit patients anatomically suitable EVAR. She presented the results from the EVAR 1 (UK), DREAM (Netherlands), ACE (France) and OVER (US) trials.

In regards to recruitment two of the trials, OVER and EVAR 1 recruited the target number (EVAR 1 target number – 900, final number– 1,252; OVER target number –872, final number – 881), whereas the DREAM and ACE trials did not achieve their recruitment targets (DREAM target number – 400, final number –351; ACE target number – 600, final number – 306).

Brown reported that there were noted patient differences between the trials. For example in the EVAR 1 trial the mean age was 74 years, whereas in the DREAM and
OVER trial the mean age was 70 years. In the EVAR 1 and DREAM trial 90% of patients were male and in the OVER trial 99% were male. The mean AAA size in the
EVAR 1 trial was 6.5cm, but was lower in the DREAM (6.1cm) and OVER (5.7cm) trials. There were also differences in aspirin use between the trials (DREAM [40%], EVAR [53%] and OVER [59%]. Finally, there were also differences between the trials in the type of stent graft device utilised (EVAR, DREAM: Zenith/Talent/Gore- OVER: Zenith/Gore/AneuRx).

“However, despite these differences, the results show a clear consensus on operative mortality,” said Brown. Other results across the trials showed a similar two year survival rate of approximately 85–90%, although the OVER trials showed a lower AAA-related mortality. In addition, there were no differences for erectile dysfunction, health related quality of life scores and the trials reported similar overall costs. However, complications and re-interventions differences were difficult to ascertain due to differing reporting protocols and cost effectiveness decisions vary between the trials.

Interestingly, there were differences between the trials in regards to all cause mortality catch up (the point at which the all-cause mortality rate between both EVAR and open repair groups was the same).

For example, in the EVAR 1 trial the catch up was recorded at two years after randomisation (Lancet 2005;365: 2179-86); in the DRAM trial the catch up was recorded at 12 months (NEJM 2005; 352: 2398-405); however in the OVER trial no catch has been recorded at two years (JAMA 2009; 302: 1535-1542). Moreover, Schermerhorn et al (NEJM 2008; 358: 464-74) reporting US Medicare data have shown all-cause mortality catch-up (from 45,660 patients) at three years.

Additional insights from these trials will be available in the coming months with the long-term results from the EVAR 1 and DREAM trials reporting later in 2010. The early-mid term results from the ACE trials are to be published imminently, with the long-term results from ACE and OVER to be published in 2012.

New TEVAR devices

Tue, 27 Apr 2010 00:00:00 GMT

Several devices are currently available to treat thoracic pathologies, differing with respect to design, metallic composition and structure of the stent, and presence or absence of an active method of fixing the device to the aortic wall.

RESCUE trial: Valiant device

Launched in October, 2009, the Captivia Delivery System for the Valiant Thoracic Stent Graft (Medtronic) is a minimally invasive treatment for aneurysms and other lesions of the thoracic aorta. The Captivia Delivery System features tip capture for enhanced control of the stent graft during deployment and a hydrophilic coating applied to the graft cover to facilitate iliac access and delivery through patients’ vasculature.

The Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System for the Endovascular Treatment of Blunt Thoracic Aortic Injuries (RESCUE) study is currently recruiting patients and is expected to be completed by early 2011.The purpose of the study is to determine if the Valiant stent graft is safe and efficient in treating patients who have a blunt thoracic aortic injury (BTAI).

Primary outcome measures include all patients are alive (up to 30 days after implant) and secondary outcome measures are successful delivery and deployment of the stent graft, device, procedure and/or aortic related adverse events, and aortic related mortality (30 days after implant).

Patients included are those with a blunt thoracic aortic injury. Excluded patients include those who have received a previous stent or stent graft or previous surgical repair in the descending thoracic artery (DTA); have a history of bleeding diathesis, coagulopathy, or refuses blood transfusion; have a known allergy or intolerance to the device components; and have a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

TX2

Cook’s new TX2 Pro-Form endograft, which has now obtained FDA approval, utilises an improved delivery system that allows for carefully controlled deployment of the endograft to help establish proximal conformity of the device to the aortic wall.

At the recent CX Vascular conference, London, UK, Mr Matt Thompson explained, “The challenges in the deployment are to achieve stability in high haemodynamic forces, attachment and sealing in proximal sealing zone, conformability to difficult angulated arch and long-term resistance to migration. If there was a fault with some of the early designs it was with conformability and achieving a seal in that angulated area just at the level of the left subclavian artery, the recent Proform modification that slightly deforms the proximal stent and allows it to make early contact with the aorta is a significant advantage.”

Furthermore, “the TX2 should be used particularly for the sort situation when you have a descending thoracic aneurysm finishing just between the level of the superior mesenteric artery and the coeliac access. We want to deploy at the level of the superior mesenteric artery and have distraction forces constrained by the axial fixation disc,” said Thompson.

TAG

Gore recently announced the first human implants of the next generation Conformable Gore TAG Thoracic Endoprosthesis in the US for the treatment of traumatic transection of the thoracic aorta. The commercially available GORE TAG Thoracic Endoprosthesis is a minimally invasive option for safely and effectively treating patients with descending thoracic aortic aneurysms. It is comprised of an ePTFE graft with an outer self-expanding nitinol support structure to combine both device flexibility and material durability. It received pre-market approval from the FDA in 2005.

In addition to traumatic aortic transection, the next generation Conformable GORE TAG Device has been approved to investigate endovascular repair of other etiologies including thoracic aortic aneurysm and aortic dissection.

The Conformable Gore TAG Device Traumatic Aortic Transection Trial will investigate the treatment of patients with aortic diameters of 16–42 mm.

CREST: CEA and CAS similar in overall long-term safety and efficacy

Tue, 27 Apr 2010 00:00:00 GMT

The Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), funded by the National Institute of Neurological Disorders and Stroke with supplemental funding by Abbott Vascular, is the largest randomised clinical trial comparing the CEA to the CAS to prevent stroke among patients with and without symptoms.

The RX ACCULINK Carotid Stent System (Abbott Vascular) was the stent used in the trial, and includes a self-expanding nickel-titanium stent pre-mounted on a rapid exchange stent delivery catheter. The delivery system is comprised of a retractable sheath covering the stent during delivery, a radiopaque tip, an internal guide wire lumen, a handle assembly with a safety lock, and a pullback handle. With the handle in the unlocked position, retracting the pullback handle removes the sheath and deploys the stent. Upon deployment, the stent forms an open lattice, providing the scaffolding necessary to hold the artery open and ensure blood flow through the artery.

The stent system is available in a range of stent lengths and diameters, and in straight and tapered configurations. Stent ends should be sized between the 1.1:1 and 1.4:1 stent-to-artery ratio. Tapered stents are designed to provide appropriate stent apposition when there is a distinct difference between vessel diameters at each stent end. The proximal stent end is sized to the common carotid artery (CCA) and the distal end is sized to the internal carotid artery (ICA).

According to lead investigator, Dr Thomas G Brott, Mayo Clinic, Jacksonville, Fl, “We found that the two procedures were similar with regard to the study’s primary endpoint – overall incidence of stroke, MI and death.” He added, “We also found that the rates of these events were low, and that safety for patients with and without symptoms was as good as any reported in any randomised carotid intervention trial.”

The primary aim of CREST is to contrast the relative effectiveness of CAS versus CEA in preventing stroke, MI, and death. Researchers randomised 2,502 patients – 35% were female and 9% minorities – to receive either CEA or CAS at more than 100 North American hospitals. More than 80% of the participants had an artery blockage greater than 70%.

The prospective, randomised, parallel, two-arm, multi-centre trial included patients who have experienced a transient ischaemic attack (TIA), amaurosis fugax (AF), or non-disabling stroke within the past 180 days, and who have an ipsilateral carotid stenosis >=50% by angiography or >=70% by ultrasound or >= 70% by CTA or MRA. Also included were patients who have carotid stenosis >=60% by angiography or >=70% by ultrasound or >= 80% by CTA or MRA.

Excluded patients included those who have comorbid conditions that interfere with the evaluation of endpoints, that are known to interfere with the completion of CEA or CAS, or that affect the likelihood of survival for the four-year study period.

Dr Brott and his colleagues found that in the 30-day period following the procedure, the rate for stroke was 2.3% in the surgical patients and 4.1% in the stenting group. However, the MI rate was higher in the surgical group, 2.3%, compared to 1.1% in the stenting group. The difference in MI and stroke between the two groups was statistically significant, explained Brott.

The researchers also found that the age of the patient made a difference in outcome. At approximately age 69 and younger, stenting results were slightly better, with a larger benefit for stenting, the younger the age of the patient. Conversely, for patients older than 70, surgical results were slightly superior to stenting, with larger benefits for surgery, the older the age of the patient.

Furthermore, researchers found that symptomatic and asymptomatic patients, and males and females, had similar outcomes in the surgical and stenting groups.

“For the present, stenting offers a reasonable alternative to carotid artery surgery,” Brott said. “For younger patients, carotid stenting appears to be a very useful tool,” he concluded.

EVAR 1 and 2: 10-year follow-up results published

Tue, 27 Apr 2010 00:00:00 GMT

Principal investigator Professor Roger Greenhalgh, and trial manager Louise C. Brown, recently presented the 10-year follow-up results from the UK’s EVAR 1 and EVAR 2 trials of endovascular aneurysm repair (EVAR) versus open repair of abdominal aortic aneurysm (AAA) at the 2010 Charing Cross International Symposium, London. The findings were also published online ahead of print in the New England Journal of Medicine. EVAR 1 studied patients deemed fit for open surgical repair, and EVAR 2 studied patients deemed unfit for open surgical repair.

EVAR 1 demonstrated a significantly lower operative mortality than open surgical repair of AAA, however, the investigators concluded that no differences were seen in total mortality or aneurysm-related mortality in the long-term. EVAR was also associated with increased rates of graft-related complications and reinterventions and was more costly.

As explained in an article published in Endovascular Today, the study was composed of 1,252 patients presenting with large AAAs (≥5.5cm in diameter) at 37 hospitals in the UK from 1999 through 2004. The investigators randomly assigned the patients to undergo either EVAR or open repair; 626 patients were assigned to each group. Patients were followed for rates of death, graft-related complications, reinterventions, and resource use until the end of 2009. Logistic regression and Cox regression were used to compare outcomes in the two groups.

The investigators reported that the 30-day operative mortality was 1.8% in the EVAR group and 4.3% in the open repair group. The EVAR group had an early benefit with respect to aneurysm-related mortality, but the benefit was lost by the end of the study, at least partially because of fatal endograft ruptures. By the end of follow-up, there was no significant difference between the two groups in the rate of death from any cause. The rates of graft-related complications and reinterventions were higher with EVAR, and new complications occurred up to eight years after randomisation, contributing to higher overall costs.

In the EVAR 2 study of AAA patients who were physically ineligible for open repair, the investigators found that EVAR was associated with a significantly lower rate of aneurysm-related mortality than no repair. However, EVAR was not associated with a reduction in the rate of death from any cause. Also, the rates of graft-related complications and reinterventions were higher with endovascular repair, and it was more costly than not intervening.

EVAR 2 was composed of 404 patients considered ineligible for surgery presenting with large AAAs (≥ 5.5cm) at 33 hospitals in the UK from 1999 through 2004. The EVAR 2 investigators randomly assigned the patients to undergo either endovascular repair (n = 197) or no intervention (n = 207). Patients were followed for rates of death, graft-related complications, reinterventions, and costs until the end of 2009. Cox regression was used to compare outcomes in the two groups.

The EVAR 2 investigators found that the 30-day operative mortality was 7.3% in the EVAR group. The overall rate of aneurysm rupture in the group with no intervention was 12.4 per 100 person-years. Aneurysm-related mortality was lower in the EVAR group. This advantage did not result in any benefit in terms of total mortality. A total of 48% of patients who survived EVAR had graft-related complications, and 27% required reintervention within the first six years. During eight years of follow-up, endovascular repair was considerably more expensive than no repair.

According to Matt Thompson, St. George’s Hospital, London, “The most significant new finding of these trials was the lower rate of aneurysm-related death in the patients considered unfit for open surgical intervention (EVAR 2) and suggests a benefit to endovascular repair in these patients. The interpretation of the trials, and in particular the reintervention rates, must be done with the knowledge that the trials reflect the state of endovascular practice at the time of patient entry into the trials a decade ago.”

DEFINITIVE AR pilot study: Combining DEB with the TurboHawk device

Tue, 27 Apr 2010 00:00:00 GMT

ev3 recently announced the launch of the TurboHawk system for use in all plaque morphologies, including calcified lesions. Based on their SilverHawk peripheral plaque excision system, which was originally cleared for use by the FDA in 2003, the TurboHawk incorporates changes in the geometry and material of the cutter structure to treat calcified lesions that may be resistant to conventional treatment.

According to the company, the TurboHawk features a cutter blade with four angled breakers for added performance when addressing all plaque morphologies, a catheter jog to provide consistent cutter apposition force, and a newly designed drive shaft to improve cutting efficiency. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device.

DEFINITIVE AR study

Medrad Interventional/Possis announced the initiation of a supply agreement with ev3 for Medrad to provide its Cotavance peripheral drug-eluting balloon (DEB) angioplasty catheter with Paccocath drug technology for study in combination with ev3’s SilverHawk and TurboHawk plaque excision systems in the DEFINITIVE AR European pilot study for treating lower extremity peripheral arterial disease.

The DEFINITIVE AR study is a prospective, multi-centre, randomised pilot study evaluating the use of either the TurboHawk or SilverHawk systems followed by treatment with the Cotavance drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease. The pilot study will evaluate up to 125 patients in Europe and is anticipated to begin in the second half of 2010. The companies anticipate that a global, multi-centre, pivotal trial will follow the completion of the pilot study. Professor Thomas Zeller, MD, and Professor Gunnar Tepe, MD, will lead the study.

According to Tepe, “Drug-eluting balloons with Paccocath technology demonstrated encouraging safety and efficacy results in the THUNDER and FemPac trials. However, I believe that treatment outcomes could be improved by first removing plaque from the vessel with plaque excision prior to using a drug-coated balloon. The combination of TurboHawk or SilverHawk plaque excision followed by the use of the Cotavance balloon catheter may allow for enhanced drug uptake and an improved acute result and durability in the treated vessel.”

UFE and myomectomy show similar fertility rates

Tue, 27 Apr 2010 00:00:00 GMT

Uterine fibroid embolization (UFE) has a comparable fertility rate to myomectomy, the surgical removal of uterine fibroids, for women who want to conceive, according to the first study on the subject released at the recent SIR meeting.

“This study is significant because it shows comparable fertility rates between the two primary uterussparing treatments widely available to treat fibroids: UFE and surgical
myomectomy, which is considered the gold standard for symptomatic fibroids in women who wish to conceive,” said Dr João Martins Pisco, St Louis Hospital, Lisbon, Portugal. “These results are surprising because other studies have favoured surgical myomectomy over UFE for women who want to conceive.”

In the study of 743 women, UFE had a fertility rate of 58.1%, which is comparable to surgical fibroid removal (myomectomy), which has a fertility rate of 57%, explained Pisco.

“Our study proves that UFE not only allows women who were unable to conceive to become pregnant but also allows them to have normal pregnancies with similar complication rates as the general population in spite of being a high risk group,” he added. “In the future, UFE will probably be a first-line treatment option even for women who wish to conceive and are unable due to the presence uterine fibroids,” he noted.

New research shows vertebroplasty for patients with osteoporosis provides effective pain relief

Tue, 27 Apr 2010 00:00:00 GMT

At the recent Society of Interventional Radiology (SIR) meeting, new research showed that patient selection is key for vertebroplasty to be effective and successful. In a study of more than 1,500 patients who were followed over seven years, 2,251 osteoporotic patients (1,811 women; average age, 65) suffering from backpain for vertebral collapses (MRI confirmed) underwent a clinical interview.

Vertebroplasty was performed in 1,542 patients (1,302 women; average age, 73) when optimal medical treatment (such as biphosphonates, teriparatide, analgesics and back brace) did not help relieve pain or improve quality of life for patients over a three-month period. After vertebroplasty, patients continued to receive medical treatment with a rheumatologist.

In 1,494 patients (96.9%), the average pre-treatment pain score on the 11-point visual analog scale was 8.2±1.8, and it dropped significantly to an average of 1.1±1.6 after vertebroplasty treatment. The Oswestry Disability Questionnaire (ODQ) scores changed from an average of 68.7±7.6% to 18.5±8.2%. Long-term follow-up (average, 31.2 months) in 1,017 patients (857 women; average age, 72) showed the visual analog score (VAS) significantly dropping from 7.9±1.5 to 1.3±1.7. Of the 757 patients wearing a back brace before vertebroplasty, 683 could stop wearing one after treatment.

Lead researcher Dr Giovanni C Anselmetti, Institute for Cancer Research and Treatment in Turin, Italy, said additional studies need to be performed, such as a large randomised trial comparing conventional medical treatment to medical treatment plus vertebroplasty.

An overview of simulators

Wed, 10 Dec 2008 00:00:00 GMT

Introduction

A summary of the subjective opinions of Interventional Radiologists regarding selected medical simulations by WE Lewandowski and DA Gould.

This article aims to reflect the subjective opinions of Interventional Radiologists regarding the ability of medical simulators, manufactured by three different vendors, to replicate key procedural tasks in the carotid, contralateral iliac and renal arteries. The data obtained also provides feedback to the medical simulation industry on the opinions of Interventional Radiologists as to the realism and fidelity of aspects of the carotid, contralateral iliac and renal procedures in the various simulators. It is important to note that the data discussed in this article was collected during the period September – November 2006, and thus represents a snapshot in time regarding the capabilities of the various simulations discussed below. The authors are aware that all of the simulation manufactures have modified their products since the data was originally collected.

Background

Simulations of varying degrees of effectiveness have been developed to support training for a large number of medical specialties from anesthesiology to urethroscopy. Interventional Radiology is no exception with still-evolving simulations available from vendors in carotid, iliac and renal procedures. A critical factor in these simulations is presentation to the operator of visual cues in a virtual fluoroscopic image, challenging the operator’s decision making and procedural sequencing. Tactile cues are also perceived via a human-computer interface device which aims to replicate the subtle feel transmitted through guide wires, catheters, and other interventional devices in patients. Yet little is known about these low level cues and their importance in the many procedural steps that are performed automatically by the experienced operator.

A number of studies and papers have been presented in medical literature and society meetings analyzing the various aspects of medical simulation including efficacy, transfer of training and validation (1-8). In our opinion, however, what has not been done is to provide practical information to the Interventional Radiology community that would be immediately useful in the decision process as to how to integrate medical simulation into curricula.

By definition, a simulation is not reality; it is an imperfect reflection. While modern technology has made amazing advances in its ability to replicate complex aspects of reality such as tissue deformation, fluid dynamics and touch (9), at least for the foreseeable future, the fidelity of sensory reproduction in medical simulation will not be the equivalent of sensory experience in reality. Because of this, there will be some aspects of a simulated procedure that will be less than acceptable for training. Conversely, there will be other aspects of the procedure that will be considered adequate.

In this study (September – November 2006) we relate aspects of the medical simulation experience that have been considered by subject matter experts (SME) to be acceptable in simulators manufactured by three different vendors (10-12). There follows a description of each of these simulators as they existed during the period September to November 2006.

CathLabVR™

The CathLabVR™ Surgical Simulator (formerly the Endovascular AccuTouch® System: Immersion Medical, Gaithersburg, UA) is claimed to demonstrate capability to “allow clinicians to practice coronary, carotid and peripheral vascular interventions, cardiac pacing, and cardiac valve replacements. The CathLabVR virtual reality system, which simulates the look and feel of actual surgeries, helps clinicians to develop skills prior to performing on patients and to maintain those skills throughout their professional practice” (10). At the time of this study, the CathLab simulation we used demonstrated a range of cases scenarios in one anatomical region, the Carotid artery, in support of Interventional Radiology, carotid stent training.

Procedicus VIST – Radiology simulator

Procedicus VIST^TM – Radiology simulator

Mentice, a Swedish-based medical simulation company, manufactures an endovascular simulator called the Procedicus VIST^TM – Radiology simulator. At the time of the study (September – November 2006), Carotid, Iliac and Renal simulations were available to support Interventional Radiology.

The VIST system claims: “highly realistic simulation based training of renal, carotid and iliac stenting using realistic 3D patient anatomies, real nested tools, tactile feedback, different cases /scenarios and complications. The Procedicus VIST^TM system consists of an interface device, a computer and two displays - one for the fluoroscopic image and one for the instructional system. The interface device is the virtual patient, with an introducer in place. Through this, the different real life tools and devices can be introduced - actual tools are used (and are re-used). All tools are active and can be manipulated at any time in the procedure. The interface and the tools (catheters, balloons, guide wires, etc.) interact with the simulation through a software package generating the fluoroscopic display, the forces that are reflected in the tools (for tactile feedback), the contrast flow, hemodynamics and the results of the simulated intervention. The web based user interface guides the user through the procedure and facilitates for self-learning” ⁽11).

ANGIO Mentor™ simulator

Simbionix is a US-based medical simulation company that manufactures an endovascular simulator called the ANGIO Mentor™ simulator. At the time of the study (September – November 2006), it had Carotid, Iliac and Renal simulations to support Interventional Radiology.

For the ANGIO Mentor™, Simbionix claims that it is designed “ … to enhance skills across the range of invasive percutaneous cardio/endovascular techniques, including diagnostic angiography, angioplasty intervention, administering thrombolytic agents, and capabilities for recognition and management of developing complications. The use of the ANGIO Mentor™ simulator by interventional cardiologists and radiologists results in a higher level of professional skills, allowing them to provide patients with better care”(12).

Clinical findings/procedure details

This proposal has been part funded by a grant from CIRSE Foundation and commenced with an abbreviated task analysis for each of the target procedures. The procedural task analyses were then sent to representatives of each of the simulator manufacturers for their concurrence that the task analyses reasonably reflected those aspects of the target procedures the various simulators were designed to simulate. Next, the task analyses were sent to Interventional Radiologists, recommended by CIRSE, for review. The final task analyses were then combined with questions on respondents’ biographical backgrounds and converted into a survey. The draft surveys were then sent to the CIRSE review panel for final concurrence.

The survey was primarily conducted at the September 2006 CIRSE meeting in Italy, and then again at the smaller November 2006 BSIR meeting in England. These meetings were chosen to take advantage of the wide range of Interventional Radiologists in attendance. At both of those meetings, the medical simulation vendors had been invited to set up their devices in an area set-aside for that purpose (Immersion Medical was not present at BSIR). Meeting attendees were requested to use the various simulators, dependent on the time available, and to then complete the surveys. An area was designated to return completed surveys.

Respondents were self-selecting, and free to use any, or all, of the simulators as often as they desired: no effort was made to control the actions of the respondents and not every respondent chose to review all three simulators. During their use of each simulator, they were assisted either by a vendor’s technical supporter or by another conference attendee.

The completed surveys were collected, collated and analyzed by the authors. The survey is reproduced below with the participants’ collated responses, embedded. Black text represents the survey itself as seen by the participants. The various colored graphs, and the red text are the collective responses. Where comments were provided by the respondents, they have been recoded here without editing.

SURVEY (WITH RESULTS) DISTRIBUTED AT CIRSE CONFERENCE SEPTEMBER 2006 AND BSIR NOVEMBER 2006

General Biographical Information (26 respondents)

1. Years in Interventional Radiology (or other interventional) Practice?

Median 13 years +/- 9.23

2. Age? _

Median 45 years +/- 8.46

3. What is your gender?

Male = 24, Female = 2.

4. In what country or countries are you licensed to practice medicine?

5. How would you describe your level of experience with the use of computers?

Very experienced: 42%

Somewhat experienced: 58%

6. Have you used a medical simulator in any type of training program?

Yes: 15

No: 11

If you have answered “Yes” please provide details:

‘Previous Simulation [?]’

‘During the French annual congress. During a renal interventional procedure training.’

‘Guidant JFR 2003’

‘Clinical decision making in trauma patients (theoretical simulation).’

‘In a Cordis training program’

‘STUD+, DATS, Congress’

‘Guidant renal simulation in Brussels’

‘Saw and tried a surgical model. Carotid stent Mentice.’

‘Mentice, Simbionix, MSC and Immersion’

7. In the chart below, please write in the year you started performing the indicated procedures:

8. In the chart below, please indicate when you trained to perform the following procedures:

9. In the chart below, please indicate how many of the following procedures you perform in a year:

Carotid Procedure – The Immersion Medical Simulation

10. The tasks below are those generally associated with performing a Carotid Procedure. Please indicate the degree to which you either agree or disagree that the Immersion Medical simulator realistically simulates a particular task by circling the appropriate number (1= strongly disagree; 2= somewhat disagree; 3= acceptable; 4= somewhat agree; 5= strongly agree). If you feel that a given task is not simulated at all, please circle “NA”.

TABLE 1

Comments:

“Has complications - good. Has adjunct drugs - good. Stable machine.”

“Not very realistic. Doesn't exchange guidewires, catheters only pull back 10-20 cm. Uses same catheters/guidewires[?] realism of exchanging.”

“The machine crashed during the procedure.”

Carotid Procedure – The Mentice Simulation

11. The tasks below are those generally associated with performing a Carotid Procedure. Please indicate the degree to which you either agree or disagree that the Mentice simulator realistically simulates a particular task by circling the appropriate number (1= strongly disagree; 2= somewhat disagree; 3= acceptable; 4= somewhat agree; 5= strongly agree). If you feel that a given task is not simulated at all, please circle “NA”.

Table 2

Comments:

“Mentice simulation vessels look less than Simbionix. Spontaneous catheter movements in desc. Aorta without manipulation. Report after procedure less than Simbionix. Auto centering option is great feature.”

Contralateral Iliac Procedure – The Mentice Simulation

12. The tasks below are those generally associated with performing an Iliac Procedure. Please indicate the degree to which you either agree or disagree that the Mentice simulator realistically simulates a particular task by circling the appropriate number (1= strongly disagree; 2= somewhat disagree; 3= acceptable; 4= somewhat agree; 5= strongly agree). If you feel that a given task is not simulated at all, please circle “NA”.

TABLE 3

Comments

“Wire too long. Makes exchanges awkward and unrealistic.”

“Face validity issues. Air in syringe. Stiff wire end.”

Renal Procedure – The Mentice Simulation

13. The tasks below are those generally associated with performing a Renal Procedure. Please indicate the degree to which you either agree or disagree that the Mentice simulator realistically simulates a particular task by circling the appropriate number (1= strongly disagree; 2= somewhat disagree; 3= acceptable; 4= somewhat agree; 5= strongly agree). If you feel that a given task is not simulated at all, please circle “NA”.

TABLE 4

Comments:

“Good sensations but sometimes a too important moving of the catheter not the stent despite a gentle push through.”

“Every diagnostic aspect of the procedure is realistic. The intervention part maybe emphasize a little bit too much the tricky part (i.e. stent sliding forward or backward. The manual feeling is rather realistically rendered. Good tool to help student to understand the preliminary explanation. Very favorable opinion.”

“Have not done renal stent procedure so my comments about realism should be guarded. Excellent idea to get familiarity with tasks. Not perfect for feel of wire.”

Carotid Procedure – The Simbionix Simulation

14. The tasks below are those generally associated with performing a Carotid Procedure. Please indicate the degree to which you either agree or disagree that the Simbionix simulator realistically simulates a particular task by circling the appropriate number (1= strongly disagree; 2= somewhat disagree; 3= acceptable; 4= somewhat agree; 5= strongly agree). If you feel that a given task is not simulated at all, please circle “NA”.

TABLE 5

“Procedure should also include realistic exchange of wires. Software not yet "stable" (two lock ups).”

“Very easy exchange device. Good ? Can give drugs. Has complications. Excellent report.”

“Choice of devices is limited. I did not find the catheters/stents I use. But on the whole a very sophisticated and advanced system. I liked the additional medical [?] (drugs, vital signs, etc.) The patients [?]”

“Not bad”

Contralateral Iliac Procedure – The Simbionix Simulation

15. The tasks below are those generally associated with performing an Iliac Procedure. Please indicate the degree to which you either agree or disagree that the Simbionix simulator realistically simulates a particular task by circling the appropriate number (1= strongly disagree; 2= somewhat disagree; 3= acceptable; 4= somewhat agree; 5= strongly agree). If you feel that a given task is not simulated at all, please circle “NA”.

TABLE 6

Comments

None

Renal Procedure – The Simbionix Simulation

16. The tasks below are those generally associated with performing a Renal Procedure. Please indicate the degree to which you either agree or disagree that the Simbionix simulator realistically simulates a particular task by circling the appropriate number (1= strongly disagree; 2= somewhat disagree; 3= acceptable; 4= somewhat agree; 5= strongly agree). If you feel that a given task is not simulated at all, please circle “NA”.

TABLE 7

Comments:

“Not bad”

“A not good machine with [?] helping people.”

Conclusions

42% of the respondents reported that they had previously used a simulator in a training program, a higher proportion than we had expected. It was also informative that a significant percentage of respondents reported that they performed less than 10 of the targeted procedures per year.

In the task analysis, respondents tended to feel that those aspects of the simulation which were mostly based on cognitive skills (i.e. rules, concepts, discriminations and decision making) were simulated to an acceptable level, while those requiring fine motor skills and response to subtle changes in touch and pressure tended to be scored to a lower level of acceptability. This varied non-significantly between simulators but confirmed our expectations as to respondent’s views on fine motor actions.

As the reader reviews the results of this study, it is important to remember that this is a “snapshot” in time. It is expected that, since this study was conducted, the characteristics and capabilities of the various simulators have changed. It is also important to note the circumstances under which the survey was conducted. Medical conferences tend to be hectic affairs in which focus and concentration are very limited. On the other had, we do feel that there is some value in impressions that are gained without extensive processing.

It is our hope that the data we have presented will be useful in helping institutions to identify how the subject medical simulators might be useful as tools for teaching selected procedural aspects of Interventional Radiology in resident and fellowship programs. We feel that even though the functionality and capabilities of the simulators used in this study has changed, the data still has relevance since a number of institutions own the type and model of devices that were used in this study. In addition, we feel that the study can serve as a useful guide for evaluating current and future simulation devices. The format we use allows the reader to look at specific, key procedural tasks and review the grading of relative effectiveness of a particular simulator to realistically replicate a given task. We also feel, that it provides some valuable information back to the vendors as to what aspects of their simulation they may want to improve.

The fact that the respondents tended to feel that the simulators were not as realistic in simulating fine motor skills, as they were in simulating cognitive skills, should not be construed in too negative a light. As important as the fine motor skills are, the cognitive skills are equally a part of the procedures and are thus equally important. They too must be mastered to be able to successfully perform a procedure. Perhaps the conclusion that should be drawn is that for the cognitive skills the various simulators might be relied upon as important training devices, but at least for the specific model of simulators used in this study, this might not be the case for acquisition and perfection of fine motor skills. While residents might be taught the procedural steps of these motor skills using a simulator, other means probably have to be relied upon in order to complete the learning process. These other means rely, for now, on mentored training in patients within apprenticeship training programs.

References

1. Dankeman J., M.K. Chmarra, E.G.G. Verdaasdonk, L.P.S. Stassen, C.A. Grimbergen. Fundamental aspects of learning minimally invasive surgical skills - Review. Minimally invasive Therapy and Allied Technologies, 2005; 14: 247-256.

2. Gallagher AG, Ritter M, Champion H et al. Virtual reality simulation for the operating room: proficiency based training as a paradigm shift in surgical skills training. Annals of Surgery, 2005; 241:364-372

3. Gould DA, Reekers JA, Kessel DO, Chalmers NC, Sapoval M, Patel AA et al., CIRSE. Simulation devices in interventional radiology: caveat emptor. Cardiovasc Intervent Radiol 2006 Jan-Feb;29(1):4-6.

4. Gould DA, Kessel DO, Healey AE, Johnson SJ, Lewandowski WE. Simulators in catheter based interventional radiology: training or computer games? Clin Radiol 2006;61:556-561.

5. Agarwal R, Black SA, Hance JR, Darzi A, Cheshire NJW. Virtual reality simulation can improve inexperienced surgeon’s endovascular skills. Eur J Endovasc Surg 2006;31:588-593.

6. Letter / comment: D Kessel, D Gould, W Lewandowski. Virtual Reality Simulation Training can Improve Inexperienced Surgeons’ Endovascular Skills. Eur J Vasc Endovasc Surg (Vol 33) Feb 2007: p259.

7. Hsu JH, Younan D, Pandalai S, Gillespie BT, Jain RA, Schippert DW et al. Use of computer simulation for determining endovascular skill levels in a carotid stenting model. J Vasc Surg 2004;40(6):1118e1124.

8. Dayal R, Faries PL, Lin SC, Bernheim J, Hollenbeck S, Derubertis B et al. Computer simulation as a component of catheter based training. J Vasc Surg 2004;40(6):1112e1117.

9. F. P. Vidal, F. Bello, K. W. Brodlie, D. A. Gould, N. W. John, R. Phillips, and N. J. Avis. Principles and Applications of Computer Graphics in Medicine. Computer Graphics Forum, Blackwell, 25(1):113–137, 2006.

10. Immersion Medical, Endovascular AccuTouch Simulator website: http://www.immersion.com/medical/products/endovascular/index.php. (accessed 24 June 2007).

11. Mentice Procedicus VIST-Radiology. Carotid and Renal stenting: website. http://www.mentice.com/. (accessed 24 June 2007).

12. Simbionix: ANGIOMentor: website. http://www.simbionix.com/ANGIO_Mentor.html. (accessed 24 June 2007).