Gore Initiates Pivotal Study for Investigational Iliac Branch Stent Graft

FLAGSTAFF, Ariz. – W. L. Gore & Associates' medical business has commenced patient enrollment in the IBE Plus Pivotal Study. This clinical trial will assess the safety and effectiveness of the investigational GORE® EXCLUDER® IBE Plus Stent Graft for patients with aortoiliac and common iliac artery aneurysms.

The first procedures were performed by Shahab Toursavadkohi, MD, National Principal Investigator at the University of Maryland, and Aleem Mirza, MD, Principal Investigator at Orlando Regional Healthcare System. Abdominal aortic aneurysms, which affect an estimated 200,000 people annually in the US, can extend into the iliac arteries, presenting treatment challenges not always met by current devices.

The study is a prospective, nonrandomized, multicenter trial that aims to enroll patients across approximately 30 sites in the United States. Participants will be followed for up to five years. The trial is designed to gather critical data on the device's performance in a real-world setting.

Physicians involved highlighted the clinical need for such advancements. "Maintaining internal iliac artery perfusion remains a key consideration in treatment planning," stated Dr. Toursavadkohi. "This study is an important milestone in the development of treatments to potentially expand iliac branch repair for more patients." Gore has a long-standing history in developing minimally invasive treatments for aortic disease, and this trial represents an extension of that focus to iliac artery interventions.