Five-year results of the Gore Excluder IBE pivotal study confirm safety, efficacy and durability

737
Gore Excluder iliac branch endoprothesis

W L Gore & Associates (Gore) has announced that five-year results from the US prospective, multicentre study (n=63) evaluating endovascular repair of iliac aneurysms using the Gore Excluder iliac branch endoprosthesis (IBE) were presented at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online). Results of the study confirmed the safety, efficacy, and durability of the IBE for treatment of aortoiliac and iliac artery aneurysms.

The Gore Excluder IBE was approved by the US Food & Drug Administration (FDA) in February 2016. According to a press release, it was the first off-the-shelf aortic branch device approved in the USA 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 IBE for the treatment of iliac artery aneurysms,” said Darren B Schneider (Penn Medicine and the University of Pennsylvania School of Medicine, Philadelphia, USA), 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.


LEAVE A REPLY

Please enter your comment!
Please enter your name here