Table of contents

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

GORE® EXCLUDER®

 

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.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

Kleiner Device Labs will attend the meeting and looks forward to demonstrating the new KG®2 Surge® flow-thru interbody system to surgeons
“Medtronic is continuing our efforts to stop Axonics from profiting off of their unauthorized use of our innovations and intellectual property," said Mira Sahney, president of the pelvic health business in the neuroscience portfolio at Medtronic. "The pattern is clear: Axonics uses Medtronic technologies to improperly compete in the market. It is time for Axonics to be held accountable for these unlawful acts."
The addition of Frank J Veith, MD to the Board underscores ViTAA's commitment to excellence and innovation in the development of medical technologies. His vast experience and achievements will provide critical insights and direction as ViTAA continues to pursue its goal of revolutionizing patient care through cutting-edge solutions.
Ultralife Corporation will join forces with cart manufacturer Karta to launch a complete medical cart and power solution on booth 1237 (Hall A) at HIMSS, from March 12-14, 2024 at the Orange County Convention Center in Orlando, Florida.
“It’s exciting to be one of the first two hospitals in Europe to use Stryker’s Mixed Reality Guidance System,” said Professor Berhouet. “I am also pleased to be leading a pilot study to investigate the safety and effectiveness of this new technology, alongside three other centres in France.”

By using this website you agree to accept Medical Device News Magazine Privacy Policy