Reviews of the Cordis ExoSeal Vascular Closure Device | Which Medical Device
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Cardio-thoracic
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Vascular closure devices
Interventional Radiology
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Vascular
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Closure devices
The ExoSeal vascular closure device allows prompt closure of femoral artery catheterisation sites. It reduces time to reambulation and hospital discharge. The device has an extra arterial absorbable plug (Polyglycolic Acid) vanishing in 60 to 90 days. The most important difference between ExoSeal and other products is the complete extra vascular placement of the device, positioned through the existing 5F or 6F procedural sheath, which is thought to lower the risk of distal embolization and infection.
The ExoSeal™ vascular closure device allows prompt closure of femoral artery catheterisation sites. It reduces time to reambulation and hospital discharge. The device has an extra arterial absorbable plug (Polyglycolic Acid) vanishing in 60 to 90 days. The most important difference between ExoSeal™ and other products is the complete extra vascular placement of the device, positioned through the existing 5F or 6F procedural sheath, which is thought to lower the risk of distal embolization and infection.
The ExoSeal™ is the most recent closure device on the market, receiving CE-Marking approval in May 2010. The manufacturer describes the ExoSeal™ as a third generation painless closure device.
ExoSeal™ device seals the site of arterial puncture releasing a PGA plug (Polyglycolic Acid) through the existing procedural sheath. The plug itself completely dissolves into carbon dioxide and water over about three months. Two visual indicators help the clinician to 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. Because none of the plug is inserted into the artery itself, it does not interfere with blood flow, reducing the risk of distal embolization, infection or other major adverse events
The 6F version has been on the European market since June 2010, the 5F version will arrive in January 2011. The device is intended to be easy to use: after saline flushing of the normal procedural sheath the device is inserted until a black indicator becomes visible on the body of the ExoSeal. The sheath is then retracted over the plug until a mechanism delivers a small nitinol guidewire. A double “visual feedback” allows the operator to “see arterial blood” from an external cannula and have an exact deployment on the outer part of the vessel wall. After plug release, 2 minutes of gentle pressure is required to ensure haemostasis. Ambulation is proposed by the manufacturer at 6 hours or later.
Out of 50 devices used at our institution no complications or rebleeding were observed despite the learning curve of all 5 IR’s enrolled in the certification program set by the manufacturer.
All the interventionalists were expert on the AngioSeal device and had no problem “shifting their mind” to the new device.
Two non-randomized studies has been conducted in Mexico and Germany. A multicentric study in the US where the 6F ExoSeal™ was compared with manual compression in patients undergoing diagnostic and interventional coronary/peripheral procedures enrolled 488 patients, 253 of those underwent ExoSeal™ and were evaluable at 30 days from the procedure. Endpoint of the trials were time to haemostasis, time to ambulation and the 30-day combined rate of access site-related complications. Results showed no major adverse events, no need for vascular repair, no access site-related infection requiring treatment in comparison with manual compression.
Future research is needed to include wider cohorts of patients also creating a register of certified users. An interesting study would be a randomised comparison with other widely used closure devices in the appropriate clinical settings.
The impression on the group is “an easy device”, probably more than others despite a longer time to ambulation recommended for patients.
No major problems were found with patients that have plaques in the puncture site, a little rotation of the device is enough to see blood flow to the outer cannula restoring the safety indicator recommended by the manufacturer .
The device is not licensed for antegrade puncture and radial access but in my opinion no major contraindications are to point out.
Large cohorts of patients will be needed to validate a product that seems to be very promising both compared to manual compression of the artery and to other closure systems for comparable puncture sizes (5 & 6F).
Dr Rodolfo Lanocita MD, Interventional Radiology Service, Fondazione IRCSS "Istituto Tumori Milano", Italy - No Conflict Declared
S. Chiu Wong, MD, William Bachinsky, MD, Patrick Cambier, MD, Robert Stoler, MD,
Janah Aji, MD, Jason H. Rogers, MD, James Hermiller, MD, Ravi Nair, MD,
Herbert Hutman, MD, Hong Wang, MD, MPH, for the ECLIPSE Trial Investigators
J. Am. Coll. Cardiol. Intv. 2009;2;785-793
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