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Gore Launches Clinical Trial for Next-Generation Iliac Stent Graft

With 200,000 Americans diagnosed with abdominal aortic aneurysms annually, W. L. Gore & Associates has initiated a pivotal clinical trial for its investigational IBE Plus Stent Graft. The study aims to address anatomical limitations in existing iliac branch devices by expanding treatment options for patients with complex aneurysmal disease.

Gore Launches Clinical Trial for Next-Generation Iliac Stent Graft

The first patients in the study were successfully implanted by Dr. Shahab Toursavadkohi at the University of Maryland and Dr. Aleem Mirza at the Orlando Regional Healthcare System. This prospective, nonrandomized, multicenter trial will monitor participants across approximately 30 sites in the United States, with a follow-up period extending to five years.

Up to 28% of abdominal aortic aneurysms extend into the iliac arteries, yet current medical devices often fall short in addressing the full range of patient anatomy. Dr. Toursavadkohi emphasized that maintaining internal iliac artery perfusion remains a primary challenge in treatment planning, noting that this research represents a critical milestone in expanding repair capabilities. The trial is designed to generate robust clinical evidence to support the safety and effectiveness of the new technology, further building on Gore’s 25-year history in minimally invasive aortic intervention.

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