AAA Endograft Clinical Studies: Can Marketed Devices Serve as Controls?
This article was originally published in The Gray Sheet
Executive Summary
Using surgical repair as a study control to abdominal aortic aneurysm endografts does not provide a good comparison arm, several clinicians asserted at a recent FDA workshop in Gaithersburg, Md
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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
AAA Workshop Participants De-Emphasize Preclinical Animal Studies
Biological response to new and modified abdominal aortic aneurysm devices should be tested in preclinical animal studies, participants agreed at an FDA workshop on AAA endografts July 28-29