Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Long-Term Data On Medtronic AAA Graft Prompts FDA Public Health Notice

This article was originally published in The Gray Sheet

Executive Summary

FDA says that new long-term data shows that the aneurysm-related mortality in patients treated with Medtronic's AneuRx abdominal aortic aneurysm (AAA) graft is "substantially higher" than the mortality rate for open surgical repair

You may also be interested in...

NEJM Study Touts Longer Lasting Survival Benefit Of Endovascular AAA Repair

The relative long-term benefits of endovascular repair versus invasive surgery for abdominal aortic aneurysms (AAA) may be greater than previously thought, according a study published Jan. 31 in the New England Journal of Medicine

Medtronic Cited For Late Postmarket Report; First “522” Action Under FDAMA

An FDA 1warning letter sent to Medtronic Sept. 27 is the agency's first enforcement action under its 1997 powers to compel device makers to collect specified postmarket surveillance data

AAA Endografts Show Early Promise In Lowering Mortality – Lancet Study

Longer-term follow-up is needed to confirm early clinical results showing a survival benefit for patients receiving endovascular aneurysm repair versus open surgery for abdominal aortic aneurysm treatment, according to an Aug. 25 Lancet study

Related Content




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts