Five-Year Data From Gore's Excluder Iliac Branch Endoprosthesis Pivotal Trial Presented at VAM 2021

August 19, 2021—Gore & Associates announced that 5-year results from the United States prospective multicenter pivotal trial (N = 63) evaluating endovascular repair of iliac aneurysms using the Gore Excluder iliac branch endoprosthesis (IBE) confirmed the safety, efficacy, and durability of the IBE for treatment of aortoiliac and iliac artery aneurysms. The data were presented by Darren B. Schneider, MD, at the Society for Vascular Surgery's 2021 Vascular Annual Meeting held August 18-21 in San Diego, California.

According to the company, the 5-year primary patency of the internal iliac artery limbs and the external iliac artery limbs after treatment with the Excluder IBE was 95.1% and 100%, respectively. 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. 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, stated Gore.

"The positive outcomes from this 5-year study validate the effectiveness and durability of the Gore Excluder IBE for the treatment of iliac artery aneurysms," commented Dr. Schneider in Gore's press release. Dr. Schneider serves as the study's National Principal Investigator. Dr. Schneider is 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."

The device was approved by the FDA in February 2016 as an off-the-shelf aortic branch device approved indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.