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HomeClinical Trials, Studies, Data Updates5-Yr Results Of The GORE® EXCLUDER® Iliac Branch Endoprosthesis Pivotal U.S. Multicenter Study Confirm Safety, Efficacy and Durability

5-Yr Results Of The GORE® EXCLUDER® Iliac Branch Endoprosthesis Pivotal U.S. Multicenter Study Confirm Safety, Efficacy and Durability



W. L. Gore & Associates (Gore), today announced that five-year results of the U.S. prospective, multicenter study (N = 63) of endovascular repair of iliac aneurysms using the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) were presented at the 2021 Society for Vascular Surgery Annual Meeting. Results of the study confirmed the safety, efficacy and durability of the IBE for treatment of aortoiliac and iliac artery aneurysms.

Approved by the U.S. Food & Drug Administration (FDA) in February 2016, the GORE EXCLUDER Iliac Branch Endoprosthesis was the first off-the-shelf aortic branch device approved in the U.S. and remains the only device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.

Five-year primary patency of the internal iliac artery and external iliac artery IBE limbs was 95.1% and 100%, respectively. Furthermore, no patients experienced new onset buttock claudication on the IBE side or new onset erectile dysfunction. Additionally, there were no Type I or Type III endoleaks and no device migrations identified by the core lab, and freedom from secondary intervention was 88.2%. The device offers a treatment option that allows patients the benefits of endovascular therapy yet preserves pelvic perfusion.

“The positive outcomes from this five-year study validate the effectiveness and durability of the GORE EXCLUDER Iliac Branch Endoprosthesis for the treatment of iliac artery aneurysms,” said Darren B. Schneider, M.D., the study National Principal Investigator and Chief of Vascular Surgery and Endovascular Therapy at Penn Medicine and the University of Pennsylvania School of Medicine in Philadelphia, Pennsylvania. “Importantly, the IBE reduces the risk of common iliac artery enlargement and rupture while maintaining patency of the internal iliac artery to prevent complications associated with internal iliac artery sacrifice.”

Used in conjunction with the GORE® EXCLUDER AAA Endoprosthesis, the IBE isolates the common iliac artery from systemic blood flow and preserves blood flow in the external iliac and internal iliac arteries. Its design allows for a two-staged repositionable deployment for precise placement and has a pre-cannulated internal iliac gate and bi-femoral delivery for ease-of-use.

The GORE EXCLUDER Iliac Branch Endoprosthesis is part of the continually growing GORE EXCLUDER Device family and GORE® TAG® Devices that share a mission to effectively treat aortic aneurysms through minimally invasive means, backed by Gore’s highly rated clinical support team and comprehensive educational offerings.

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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