Flagstaff, Ariz. (April 21, 2016) — W. L. Gore & Associates, Inc. (Gore) today announced the Health Canada approval of the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE), making it the most recent off-the-shelf aortic branch device approved in Canada for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. With more than 1,000 commercial implants worldwide, the device is a complete, fully engineered system (Gore designed iliac branch and internal iliac components), which received CE Mark in 2013, registered in Australia and New Zealand in 2015, and FDA approved in February of this year.
Used in conjunction with the GORE® EXCLUDER® AAA Endoprosthesis, the IBE preserves blood flow in the external iliac and internal iliac arteries. The IBE leverages the design and experience acquired from more than 18 years and 250,000 patients treated* with the GORE EXCLUDER Device and utilizes the same durable, expanded polytetrafluoroethylene (ePTFE) graft and nitinol stent material.
The IBE All-in-One System advances repair with proven outcomes for the treatment of iliac artery aneurysms. As the recommended treatment of vascular surgery societies, the preservation of blood flow in the internal iliac arteries can avoid pelvic flow disruption and reduce the rate of buttock claudication, sexual dysfunction, and colonic ischemia. In the United States clinical trial, there have been no reports of buttock claudication (0%) on the IBE treatment side and no reports of new-onset sexual dysfunction (0%) through six-months follow-up.
The IBE system provides a treatment range of 6.5-13.5 mm for the internal iliac arteries, and a treatment range of 6.5-25 mm for the external iliac arteries. The delivery profile of the loaded catheter allows the use of a 16 Fr introducer sheath for the iliac branch component, and a flexible 12 Fr, reinforced introducer sheath for the internal iliac component.
“The Health Canada approval of the GORE EXCLUDER Iliac Branch Device demonstrates our commitment to providing minimally invasive devices for preserving flow to the internal and external iliac arteries,” said Ryan Takeuchi, Gore Aortic Business Leader. “The device has performed as promised with demonstrated high patency, conformability, and durability.”
Backed by Gore’s highly rated clinical support team and comprehensive educational offerings, the IBE is part of the growing family of Gore devices that share a mission to effectively treat aortic aneurysms through minimally invasive means, as well as a larger portfolio of off-the-shelf aortic branch solutions that are currently in clinical trial.
* Based on the number of Trunk-Ipsilateral Legs distributed.
ABOUT W. L. GORE & ASSOCIATES
At Gore, we have provided creative therapeutic solutions to complex medical problems for 40 years. During that time, 40 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. Our extensive family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery. We are one of a select few companies to appear on all of the US “100 Best Companies to Work For” lists since the rankings debuted in 1984.