W L Gore & Associates (Gore) has reported that five-year data from the study of its GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) for endovascular repair of iliac aneurysms confirmed its safety.
The US-based, prospective, multicentre trial established the efficacy and durability of the IBE in treating aortoiliac and iliac artery aneurysms.
In February 2016, the GORE EXCLUDER IBE obtained approval from the US Food and Drug Administration (FDA) as the first off-the-shelf aortic branch device in the country.
Primary patency of the internal iliac artery and external iliac artery IBE limbs was 95.1% and 100%, respectively, for five years.
None of the subjects experienced new-onset buttock claudication on the IBE side or new onset erectile dysfunction, Gore noted.
Furthermore, no Type I or Type III endoleaks or device migrations were reported by the core lab and freedom from secondary intervention was 88.2% in the study.
The IBE device provides a therapy option that permits patients to have the benefits of endovascular treatment while maintaining pelvic perfusion.
Penn Medicine vascular surgery and endovascular therapy chief Darren Schneider, the national principal investigator of the study, said: “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.
“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 combination with the GORE EXCLUDER AAA Endoprosthesis, the IBE separates the common iliac artery from systemic blood flow and maintains blood flow in the external iliac and internal iliac arteries.
The GORE EXCLUDER IBE’s design permits a two-staged repositionable deployment for precise implantation and has a pre-cannulated internal iliac gate and bi-femoral delivery for convenient usage.
This device is part of the growing GORE EXCLUDER Device family and GORE TAG Devices intended to efficiently treat aortic aneurysms minimally invasively, supported by the company’s clinical support team and complete educational offerings.