Canada Approves Cook Medical's Zenith Branch EV Graft-Iliac Bifurcation

November 3, 2009—Cook Medical (Bloomington, IN) announced that Health Canada's Medical Devices Bureau has approved the Zenith branch endovascular graft-iliac bifurcation, which is specifically designed to preserve flow to the internal iliac artery, allowing for the endovascular treatment of both aortoiliac and iliac artery aneurysms, which commonly occur in patients with abdominal aortic aneurysms.

The company stated that the Cook branch graft is bifurcated, like the iliac artery itself, with openings to connect the common iliac, side branch (internal iliac), and external iliac segments. Incorporating Cook's Zenith technology, the device preserves flow to the iliac artery, reducing the potential for complications such as colon ischemia, buttock and hip claudication or impairment, and impotence. The device mimics the natural iliac artery anatomy. The graft, which is completely stented, is made of thick woven polyester fabric sewn to self-expanding stainless steel and nitinol Cook-Z stents with braided polyester and monofilament polypropylene suture.

The Zenith branch endovascular graft-iliac bifurcation is also available in the European Union and Australia. It is not available in the United States, where it is currently regulated as an investigational device.

"Aortoiliac and iliac aneurysms are known to be particularly difficult to treat due to the tortuous anatomy," commented Cherrie Z. Abraham, MD. "The control and stability of Cook's branch graft offers precise deployment. The capability to preserve blood flow to the internal iliac artery is a crucial benefit, too, because it will help avoid complications that can arise from internal iliac embolization."