Gore Excluder Iliac Branch Endoprosthesis Approved in Australia and New Zealand

May 12, 2015—Gore & Associates announced that the Gore Excluder iliac branch endoprosthesis has received regulatory approval for use in Australia and New Zealand. The device, which is fully engineered with Gore-designed iliac branch and internal iliac components, is intended for endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. It has been included on the Australian Register of Therapeutic Goods.

According to the company, the new device is used in conjunction with Gore Excluder abdominal aortic aneurysm endoprosthesis components to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries. The device incorporates Gore’s expanded polytetrafluoroethylene graft.

The Gore Excluder iliac branch endoprosthesis 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 12-F, flexible, reinforced introducer sheath for the internal iliac component.

The first patient procedures in Australia were completed by Steven Dubenec, MD, Head of Department of Vascular Surgery at Royal Prince Alfred Hospital in Sydney, and Jack Loa, MD, at Macquarie University Hospital in Sydney.

In Gore’s press release, Dr. Dubenec commented, “Based on the design of the Gore Excluder device, this system provides a wide treatment range and long-term durability, which is extremely important for optimal clinical success. The precannulated branch and bifemoral delivery elements of the Gore Excluder iliac branch endoprosthesis support the ease of use of this device.”