Gore Excluder Iliac Branch Endoprosthesis Approved in Canada

April 21, 2016—Gore & Associates, Inc. announced the Health Canada approval of the Gore Excluder iliac branch endoprosthesis (IBE) for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. The Gore Excluder received European CE Mark approval in 2013, Australia and New Zealand registration in 2015, and US Food and Drug Administration approval in February 2016.

Used in conjunction with the Gore Excluder AAA endoprosthesis for treatment of abdominal aortic aneurysms, the Excluder IBE all-in-one system preserves blood flow in the external iliac and internal iliac arteries. The company noted that in the United States clinical trial, there have been no reports of buttock claudication on the IBE treatment side and no reports of new-onset sexual dysfunction through 6-months follow-up.

The IBE system provides a treatment range of 6.5–13.5 mm for the internal iliac arteries, and a treatment range of 6.5–25 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. The IBE device utilizes the same expanded polytetrafluoroethylene graft and nitinol stent material as the Gore Excluder AAA endoprosthesis, stated Gore & Associates.