Five-year results from the U.S. prospective, multicenter study evaluating endovascular repair of iliac aneurysms using the Gore Excluder iliac branch endoprosthesis (IBE) were presented at the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM) in San Diego Thursday morning, confirming the safety, efficacy and durability of the IBE for treatment of aortoiliac and iliac artery aneurysms, investigators revealed.
“The IBE device effectively prevented common iliac artery aneurysm [CIAA] enlargement while maintaining patency of the internal iliac artery and avoiding complications associated with internal iliac artery sacrifice,” they found. “Although CIAA enlargement was rare, abdominal aortic enlargement was more common, suggesting that outcomes of EVAR [endovascular aneurysm repair] may be different in patients with and without associated CIAAs.”
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.
Darren B. Schneider, MD, chief of the division of vascular surgery and endovascular therapy in the University of Pennsylvania Health System, Philadelphia, presented the findings during Plenary Session 3.
“The positive outcomes from this five-year study validate the effectiveness and durability of the Gore Excluder IBE for the treatment of iliac artery aneurysms,” said Schneider, the study’s national principal investigator. “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 abdominal aortic aneurysm (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 precannulated internal iliac gate and bi-femoral delivery for ease of use.
The device was approved by the Food & Drug Administration (FDA) in February 2016.
