Gore has received U.S. FDA approval for its GORE EXCLUDER Iliac Branch Endoprosthesis (IBE).
According to the company, the approval makes the device “the first off-the-shelf aortic branch device approved in the United States and the only device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.”
“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 percent of AAA cases,” said Dr. Darren Schneider, Chief of Vascular and Endovascular Surgery and Associate Professor of Surgery at Weill Cornell Medicine. “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.”
The device was approved for implantation in Europe in 2013.
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