GORE® EXCLUDER® Iliac Branch Endoprosthesis Gains Health Canada Approval
FLAGSTAFF, Ariz., 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.
Source: W. L. Gore & Associates, Inc.
Comments