US-based W. L. Gore & Associates (Gore) has completed primary enrollment in its multi-center, non-randomized and single-arm trial, Gore Excluder Iliac Branch Clinical Study.
The trial has been designed to evaluate the safety and effectiveness of the Gore Excluder Iliac Branch Endoprosthesis in treating common iliac artery aneurysms or aorto-iliac aneurysms.
Gore aortic business unit leader Ryan Takeuchi said: "Completing primary enrollment marks a significant step toward achieving FDA approval for the Gore Excluder Iliac Branch Device."
"If approved, the iliac branch endoprosthesis would become the first and only device indicated to treat common iliac aneurysms in the US."
According to the company, a total of 62 patients have received the device, which completed the required enrollment of 60 set by the Food and Drug Administration (FDA).
In addition, FDA approved a Continued Access Protocol (CAP), which will allow an additional 140 patients to be treated with the device. It also includes use of the Gore Excluder Iliac Branch Endoprosthesis for bilateral placement.
The Gore Excluder Iliac Branch Device (iliac branch component and internal iliac component) is used in conjunction with the Gore Excluder Iliac Branch Endoprosthesis to separate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries.
In October 2013, the Gore Excluder Iliac Branch Endoprosthesis received CE mark approval to treat common iliac artery aneurysms.
Image: The Gore Excluder Iliac Branch Endoprosthesis. Photo: courtesy of Business Wire/ W. L. Gore & Associates, Inc.