GORE ANNOUNCES FIRST PATIENT ENROLLMENT IN THE GORE® EXCLUDER® IBE PLUS STENT GRAFT PIVOTAL STUDY

CAUTION: Investigational device. Limited by United States law to investigational use.

FLAGSTAFF, Ariz., Oct. 1, 2026 /PRNewswire/ -- W. L. Gore & Associates' medical business (Gore) announced today the first patient enrollment in the IBE Plus Pivotal Study, a clinical trial evaluating the investigational GORE^® EXCLUDER^® IBE Plus Stent Graft for the treatment of aortoiliac and common iliac artery aneurysms. The first patients were implanted by Shahab Toursavadkohi, MD, National Principal Investigator at the University of Maryland and Aleem Mirza, MD, Principal Investigator at Orlando Regional Healthcare System.

Every year, 200,000 people in the US are diagnosed with an abdominal aortic aneurysm (AAA), with up to 28% of AAAs extending into the iliac arteries. Despite evolving technology, existing iliac branch devices have limitations in their anatomic suitability to treat all patients.^1,2 

About the IBE Plus Clinical Trial

The IBE Plus Clinical Trial is a prospective, nonrandomized, multicenter, interventional trial designed to evaluate the safety and effectiveness of the GORE^® EXCLUDER^® IBE Plus Stent Graft in the endovascular treatment of aortoiliac and common iliac artery aneurysms. The study plans to enroll patients in 2 study arms at approximately 30 sites in the United States, with follow-up through 5 years.

"The initiation of this pivotal study is an exciting step forward for patients with aortoiliac aneurysmal disease," said Shahab Toursavadkohi, MD, National Principal Investigator from the University of Maryland. "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."

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

Advancing Iliac Branch Innovation

"Clinical research is essential to advancing endovascular treatment options," said Jill Paine, Product and Innovation Leader at Gore. "Science, engineering, and clinical evidence have long been the foundation of our innovation. The IBE Plus Pivotal Study reflects our ongoing commitment to partner with physicians and address unmet patient needs."

For more than 25 years, Gore has been a leader in aortic treatment innovation, pioneering minimally invasive treatments that have transformed care for patients with complex aortic disease. The IBE Plus Clinical Trial extends this legacy, investigating next-generation solutions for the iliac arteries.

Additional information about the study is available at https://clinicaltrials.gov/study/NCT07304102

About Gore

W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments—from outer space to the world's highest peaks to the inner workings of the human body. With approximately 13,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $5.3 billion. gore.com

1. Abdominal aortic aneurysm. Society for Vascular Surgery. Accessed July 23, 2026. https://vascular.org/your-vascular-health/vascular-conditions/common-conditions/abdominal-aortic-aneurysm
2. Gouveia E Melo R, Fenelli C, Fernández Prendes C, et al. A cross-sectional study on the anatomic feasibility of iliac side branch grafts in a real-world setting. J Vasc Surg. 2022;76(3):724-732. doi:10.1016/j.jvs.2022.02.056

SOURCE W. L. Gore & Associates, Inc. MPD Division