The benefits of a device designed for the endovascular treatment of infrarenal abdominal aortic aneurysm (AAA) outweigh the potential risks, according to a majority of members of the Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee.

Current panel chair Richard Page, MD, George R. and Elaine Love Professor and chair, Department of Medicine, commented on the decision, which followed considerable discussion of data from the multicenter, prospective, nonrandomized INSPIRATION trial.

While the panel voted 14-0 regarding device effectiveness, it split 11-4 on the question of safety. As committee chair, Dr. Page did not cast a vote.

“It appears that the device meets an unmet need,” he said during his concluding remarks to the panel.

“My sense is that none of you would use it for an uncomplicated patient, but our vascular surgery colleagues want it available to them, so they should have that tool.”

Resources:

• "FDA panel favors approval of new AAA stent graft system," CardiologyToday's Intervention, June 12, 2018

Photo (top): A contrast enhanced CT scan demonstrating an abdominal aortic aneurysm of 4.8 * 3.8 cm. (Public Domain, CC-SA-3.0, J. Heilman)