GORE EXCLUDER Iliac Branch Lands FDA Approval
W. L. Gore & Associates has won FDA approval for Gore Excluder iliac branch endoprosthesis, which is intended for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.
The device, which received CE Mark in 2013, is the first off-the-shelf aortic branch device approved in the U.S.
In a study, 62 patients received the device, according to the company, which added 32 participants through continued access. — Anisa Jibrell