Gore's Excluder Iliac Branch Endoprosthesis Approved in Europe

November 7, 2013—Gore & Associates (Flagstaff, AZ) announced European CE Mark approval for the Gore Excluder iliac branch endoprosthesis, which is intended for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.

Composed of Gore's established technology platform with its expanded polytetrafluoroethylene graft, the Excluder iliac 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.

According to the company, 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.

Gore noted that the first procedures in Europe with the newly approved device were performed by Professor Piergiorgio Cao, MD, Chief of Vascular Surgery at San Camillo Hospital in Rome, Italy; Mo Hamady, MD, Consultant Interventional Radiologist at St. Mary's Hospital in London, United Kingdom; and Michael Jenkins, MD, Consultant Vascular Surgeon and Clinical Lead at St. Mary's Hospital in London.

In Gore's press release, Dr. Hamady commented, “Gore's dedicated components for iliac artery repair provide the first complete low-profile system for managing common iliac artery aneurysms. The procedure is simple and straightforward due to the precannulated branch and bifemoral delivery system.”

Prof. Cao added, “In endovascular procedures involving iliac arteries, this device is easy to handle and repositionable for precise placement. The Gore Excluder device-based design also provides a wide treatment range and long-term durability, which is extremely important for optimal success. Additionally, the low-profile delivery provides for enhanced vessel access, benefiting patients and physicians alike.”