Enrollment Begins in Gore EXCLUDER Iliac Branch Study

November 14, 2013—Gore & Associates (Flagstaff, AZ) announced the commencement of enrollment in the Gore EXCLUDER iliac branch clinical study.

According to the company, this prospective, multicenter, nonrandomized, single-arm study is designed to assess the safety and effectiveness of the Gore Excluder iliac branch endoprosthesis for treatment of patients with common iliac artery aneurysms or aortoiliac aneurysms. Endovascular specialists will enroll 60 patients at up to 50 sites. Brian Peterson, MD, from Saint Louis University enrolled the first patient, who was treated at St. Anthony’s Medical Center in St. Louis, Missouri.

The Gore Excluder iliac branch endoprosthesis received European CE Mark approval in October 2013. In the United States, the device is currently available for investigational purposes only, advised the company.

The Gore Excluder iliac branch devices—iliac branch component and internal iliac component—are used in conjunction with the Gore Excluder abdominal aortic aneurysm endoprosthesis to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries.

In Gore’s press release, Dr. Peterson commented, “We are pleased to get this important study underway and move closer toward improved iliac artery repair. The low profile design, precannulated branch, and bifemoral delivery system proved beneficial in this first case. We look forward to the results of this important study and their implications for minimally invasive endovascular procedures involving iliac arteries.”