Gore wins FDA nod for Excluder stent graft

W.L. Gore & Assoc. said today that it won FDA approval for its Excluder stent graft for treating abdominal aortic aneurisms. The Excluder device is designed to treat aneurysms in the iliac arteries as they branch off from the aorta.

The approval, announced at the Houston Aortic Symposium, makes Gore the 1st company on the U.S. market with an off-the-shelf aortic branch device indicated for common iliac artery or aortoiliac aneurysms, the Flagstaff, Ariz.-based company said. The device won CE Mark approval in the European Union and Japanese approval back in 2013.

“FDA approval of this device is extremely important as it provides an iliac branch solution for a patient group with a previously unmet treatment need,” aortic business leader Ryan Takeuchi said in prepared remarks. “The Gore Excluder iliac branch device has demonstrated high patency, conformability, and durability and provides physicians with an on-label, minimally invasive method of preserving flow to the internal and external iliac arteries. Not only is IBE the first off-the-shelf aortic branch device approved in the United States, it is a part of a complete portfolio of aortic branch solutions that are currently in clinical evaluation.”

“Historically, options to preserve flow to the internal iliac arteries during endovascular aneurysm repair were very limited despite the involvement of the iliac arteries in about 25% of AAA cases,” added Dr. Darren Schneider, of New York City’s Weill Cornell Medicine, who is the principal investigator in Gore’s Excluder Iliac Branch Device study. “However, through our research and the subsequent FDA approval, physicians now have a new therapeutic option to preserve pelvic perfusion in order to improve clinical outcomes and maintain patient quality of life.”

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