Obtaining an IDE for Physician-Modified or Off-Label Stent Grafts

April 1, 2016

A physician’s perspective on applying for an IDE, interaction with the FDA, and practice under an IDE.

How would you briefly describe the nature of a thoracoabdominal aortic aneurysm (TAAA) and how it differs from everyday cases? How does this affect the options that treating physicians have at their disposal?

The classic definition of a TAAA is an aneurysm that spans both the thoracic and abdominal cavities. I think with endovascular options evolving, this definition is coming into question and may be based more on limits of required aortic coverage…..

Source: Endovascular TODAY
Full Story: http://evtoday.com/2016/04/obtaining-an-ide-for-physician-modified-or-off-label-stent-grafts

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