W.L. Gore & Associates said today it won Health Canada approval for its Excluder iliac branch endoprosthesis designed for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.
The IBE device is designed to be used in conjunction with Gore’s Excluder AAA endoprosthesis for treating abdominal aortic aneurisms. The Excluder device is designed to treat aneurysms in the iliac arteries as they branch off from the aorta, the Flagstaff, Ariz.-based company said.
“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. The device has performed as promised with demonstrated high patency, conformability, and durability,” aortic biz lead Ryan Takeuchi said in a press release.
In February, Gore said it won won FDA approval for its Excluder stent graft, making it the 1st company on the U.S. market with an off-the-shelf aortic branch device indicated for common iliac artery or aortoiliac aneurysms, the company said.
The device won CE Mark approval in the European Union and Japanese approval back in 2013. The Gore Excluder IBE won approval in Australia and New Zealand in 2015.
