Gore has completed primary enrolment in the Gore Excluder iliac branch clinical study, a prospective, multicentre, non-randomised, single-arm study designed to assess the safety and effectiveness of the Excluder iliac branch endoprosthesis in treating common iliac artery aneurysms or aorto-iliac aneurysms.
A total of 62 patients have received the device, which completed the required enrolment of 60 set by the US Food and Drug Administration (FDA). Additionally, the FDA approved a continued access protocol allowing an additional 140 patients to be treated with the device. The protocol also includes use of Excluder for bilateral placement.
“An estimated 20–40% of patients with abdominal aortic aneurysms have common iliac arteries that also require repair, yet no device has been approved for this treatment indication in the USA,” said Darren Schneider, chief of vascular and endovascular surgery at the Weill Cornell Medical College and principal investigator for the national trial. “This iliac branch device provides a wider range of patients with access to minimally invasive, endovascular treatment options.”
The Excluder device (iliac branch component and internal iliac component) is used in conjunction with the Excluder abdominal aortic aneurysm endoprosthesis to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries.
“Completing primary enrolment marks a significant step toward achieving FDA approval for the Excluder device,” said Ryan Takeuchi, Aortic Business Unit leader at Gore. “If approved, the iliac branch endoprosthesis would become the first and only device indicated to treat common iliac aneurysms in the USA.”
In October 2013, the Excluder iliac branch endoprosthesis became the first complete, fully engineered system (Gore designed iliac branch and internal iliac components) for treating common iliac artery aneurysms to receive the European CE mark.