Gore’s Pivotal Trial of Excluder IBE Plus Stent Graft Begins Enrollment

October 2, 2026—Gore & Associates announced that the first patients were enrolled in the pivotal study of the company’s investigational Excluder iliac branch endoprosthesis (IBE) Plus stent graft.

According to the company, the IBE Plus clinical trial is a prospective, nonrandomized, multicenter, interventional trial designed to evaluate the safety and effectiveness of the Excluder IBE Plus device in the endovascular treatment of aortoiliac and common iliac artery aneurysms. Patients will be enrolled in two study arms at approximately 30 sites in the United States, with follow-up through 5 years, advised Gore.

As noted in the Gore press release, the first patients in the trial were treated by Shahab Toursavadkohi, MD, National Principal Investigator at the University of Maryland in Baltimore, Maryland, and Aleem Mirza, MD, Principal Investigator at Orlando Regional Healthcare System in Orlando, Florida.

“The initiation of this pivotal study is an exciting step forward for patients with aortoiliac aneurysmal disease,” commented Dr. Toursavadkohi in Gore’s press release. “Maintaining internal iliac artery perfusion remains a key consideration in treatment planning. This study is an important milestone in the development of treatments to potentially expand iliac branch repair for more patients.”

Dr. Mirza added, “Aortoiliac aneurysmal disease can present unique treatment planning considerations, making continued clinical research especially important. We are excited to participate in this study and contribute to the clinical evidence being generated.”

Excluder IBE Plus stent graft is limited by United States law to investigational use, advised Gore.