FDA Approves Ground Breaking Endovascular Aortic Repair Devices

Published date : 01 October 2012
Article date : 01 October 2012

Healthcanal.com reports on 2 devices, recently approaved by the FDA apparently offer more life-saving options to patients experiencing aortic disease or injury. Both devices were tested in clinical trials at the University of North Carolina School of Medicine have been approved by the FDA.

They say that the first device, the RELAY Thoracic Stent Graft with PLUS Delivery System manufactured by Bolton Medical, is designed to treat thoracic aortic aneurysms (the 13th leading cause of death in the US) occuring in the aorta as it passes through the chest. Apparently, the device offers a range of sizes and ease of use to help to expand the use of the minimally-invasive treatment to a broader segment of patients.  The US study included more than 120 endovascular patients at 30 hospitals across the country.

Healthcanal describes the second device, the Conformable TAG Thoracic Endoprosthesis, manufactured by Gore Medical as used for endovascular repair of a traumatic thoracic aortic transection. They say that over 8,000 people each year (US) experience a transection of their aorta, involving profuse bleeding and high mortality rate - most often caused by a severe injury to the chest as a result of a motor vehicle accident, crushing of the chest, or a high fall.

Apparently, prior to the successful clinical tria, the only treatment option for traumatic thoracic aortic transection was open surgical repair; the minimally-invasive endovascular repair of traumatic thoracic aortic transection reduces recovery time and pain for patients who have experienced this type of transection.

Source: healthcanal.com, 27 September 2012

Read the full article here.

For a further report on this story, click here

Back to Listings

WhichMedicalDevice is a FREE resource created by clinicians for clinicians.

Registration is free and gives you unlimited access to all of the content and features of this website.

Find out more...

Please sign in to view this content...

I have forgotten my password
Not a Member?

Registration is free and gives you unlimited access to all of the content and features of Which Medical Device. Find out more...

Why Register

Which Medical Device is a community of clinicians sharing knowledge and experience of the devices and procedures we use on a daily basis. We ask that our members register with us so that we can maintain the unbiased and independent nature of our content. Registration is quick and free.

We do not make your details available to any third parties nor do we send unsolicited emails to our members. You can read our Privacy Policy here.