Gore Excluder iliac branch endoprosthesis gains Health Canada approval

Gore Excluder

Health Canada has approved the Gore Excluder iliac branch endoprosthesis, making it the most recent off-the-shelf aortic branch device approved in Canada for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. The device has more than 1,000 commercial implantations worldwide and received CE mark in 2013, was registered in Australia and New Zealand in 2015 and was FDA approved in February.

Used in conjunction with the Excluder abdominal aortic aneurysm endoprosthesis, the iliac branch endoprosthesis preserves blood flow in the external iliac and internal iliac arteries. The iliac branch endoprosthesis leverages the design and experience acquired from more than 18 years and 250,000 patients treated (based on the number of trunk-ipsilateral legs distributed) with the Excluder device and utilises the same durable, expanded polytetrafluoroethylene (ePTFE) graft and nitinol stent material.

Gore says that the Excluder system “advances repair with proven outcomes for the treatment of iliac artery aneurysms.” As the recommended treatment of vascular surgery societies, the preservation of blood flow in the internal iliac arteries can avoid pelvic flow disruption and reduce the rate of buttock claudication, sexual dysfunction, and colonic ischaemia. In the US clinical trial, there have been no reports of buttock claudication on the Excluder treatment side and no reports of new-onset sexual dysfunction through six months of follow-up.

The system provides a treatment range of 6.5–13.5mm for the internal iliac arteries, and a treatment range of 6.5–25mm for the external iliac arteries. The delivery profile of the loaded catheter allows the use of a 16Fr introducer sheath for the iliac branch component, and a flexible 12Fr, reinforced introducer sheath for the internal iliac component.