First Patient Enrolled in Clinical Trial to Test Gore Aneurysm Technology

The first patient has been enrolled in the Gore Excluder iliac branch clinical study, a prospective, multi-center, non-randomized, single-arm study designed to assess the safety and effectiveness of the Gore Excluder Iliac branch endoprosthesis made by Flagstaff, Ariz.-based W.L. Gore & Associates for treatment of patients with common iliac artery aneurysms or aorto-iliac aneurysms.

The patient was treated at St. Anthony’s Medical Center, in St. Louis, Mo., by Brian Peterson, M.D., from Saint Louis University.

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

Peterson said: “We are pleased to get this important study underway and move closer toward improved iliac artery repair. The low-profile design, pre-cannulated branch, and bi-femoral 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.”

“Providing the best possible patient care and fulfilling unmet clinical needs require constant innovation. Gore is committed to advancing these innovations through collaboration with the clinical community,” added Ryan Takeuchi, head of Gore’s Aortic business unit. “We are excited that endovascular specialists globally are expressing such a high level of interest in the study and in iliac artery repair solutions.”

Endovascular specialists will enroll 60 patients at up to 50 sites during the course of this study. The Gore Excluder Iliac branch endoprosthesis received CE mark in October and is currently available in the U.S. for investigational purposes only.