The Gore Excluder iliac branch endoprosthesis has become the first off-the-shelf aortic branch to be approved by the US Food and Drug Administration (FDA) according to a company release.
The product is now the only device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms in the USA. The system received CE mark in 2013.
Like other Gore endoprostheses, the device is designed expanded polytetrafluoroethylene (ePTFE) graft and nitinol stent material, which should offer durability.
The IBE is an all-in-one system, offering improved outcomes for the treatment of iliac artery aneurysms while preserving flow to the iliac arteries, according to the release.
“Historically, options to preserve flow to the internal iliac arteries during endovascular aneurysm repair were very limited despite the involvement of the iliac arteries in about 25% of abdominal aortic aneurysm cases,” says Darren Schneider, chief of Vascular and Endovascular Surgery and associate professor of surgery at Weill Cornell Medicine, New York, USA, and principal investigator for the national Gore Excluder iliac branch device clinical study. “However, through our research and the subsequent FDA approval, physicians now have a new therapeutic option to preserve pelvic perfusion in order to improve clinical outcomes and maintain patient quality of life.”
The IBE system provides a treatment range of 6.5-13.5mm for the internal iliac arteries, and a treatment range of 6.5-25mm for the external iliac arteries. The delivery profile of the loaded catheter allows the use of a 16Fr introducer sheath for the iliac branch component, and a flexible 12Fr, reinforced introducer sheath for the internal iliac component.
The Gore Excluder Iliac Branch Device Clinical Study, a prospective, multicentre, non-randomised, single-arm study designed to assess the safety and effectiveness of the IBE in treating common iliac artery aneurysms or aortoiliac aneurysms, completed enrolment in February 2015. A total of 62 patients received the device, which met the FDA required enrolment of 60 patients. The trial has also enrolled an additional 32 patients through continued access (as of February 15, 2016), which has expanded treatment options to allow for bilateral placement of the IBE in addition to unilateral IBE device placement, which was evaluated in the primary enrolment.
Ryan Takeuchi, Gore Aortic business leader, says, “The Gore Excluder iliac branch device has demonstrated high patency, conformability, and durability and provides physicians with an on-label, minimally invasive method of preserving flow to the internal and external iliac arteries.”