FDA Approves Gore Excluder Iliac Branch Endoprosthesis

March 3, 2016—Gore & Associates announced that the US Food and Drug Administration (FDA) has approved the Gore Excluder iliac branch endoprosthesis (IBE) for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. The device received European CE Mark approval in 2013.

According to the company, the Gore Excluder IBE is used in conjunction with the Gore Excluder abdominal aortic aneurysm (AAA) endoprosthesis to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries. The device is built on Gore’s proven technology platform and designed using the same durable, expanded polytetrafluoroethylene graft and nitinol stent material.

The Gore Excluder IBE all-in-one system provides a treatment range of 6.5 to 13.5 mm for the internal iliac arteries and a treatment range of 6.5 to 25 mm for the external iliac arteries. The delivery profile of the loaded catheter allows the use of a 16-F introducer sheath for the iliac branch component and a flexible 12-F, reinforced introducer sheath for the internal iliac component.

Gore advised that the device is supported by the Gore Excluder Iliac Branch Device Clinical Study, which completed enrollment in February 2015.  The prospective, multicenter, nonrandomized, single-arm study was designed to assess the safety and effectiveness of the IBE in treating common iliac artery aneurysms or aortoiliac aneurysms. A total of 62 patients received the device, which met the FDA-required enrollment of 60 patients. In this primary enrollment, unilateral IBE device placement was evaluated. An additional 32 patients (as of February 15, 2016) were enrolled in a continued-access protocol with expanded treatment options to allow for bilateral placement of the IBE.

The study's Principal Investigator is Darren Schneider, MD, Chief of Vascular and Endovascular Surgery and Associate Professor of Surgery at Weill Cornell Medicine in New York, New York.

In the company’s press release, Prof. Schneider commented, “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. 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.”