First Device Designed To Preserve Blood Flow To Iliac Arteries During Aneurysm Repair Receives Approval From Health Canada

Main Category: Vascular
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 04 Nov 2009 - 21:00 PST

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Canadian physicians can now treat patients suffering from life-threatening aneurysms in one of the body's largest arteries with an endovascular graft delivered during a minimally invasive procedure without blocking a critical artery. The Zenith® Branch Endovascular Graft-Iliac Bifurcation from Cook Medical, approved today by Health Canada's Medical Devices Bureau, is specifically designed to preserve flow to the internal iliac artery allowing for the endovascular treatment of both aortoiliac and iliac artery aneurysms that commonly occur in patients with abdominal aortic aneurysms (AAA). Aneurysms are bulges in the walls of the major arteries that left untreated can rupture causing death.

"Aortoiliac and iliac aneurysms are known to be particularly difficult to treat due to the tortuous anatomy," said Dr. Cherrie Abraham of Jewish General Hospital in Montreal. "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, as it will help avoid complications that can arise from internal iliac embolization."

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. Built on Cook's proven Zenith technology, which has been used for years in the endovascular treatment of aneurysms in other major vessels, 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 designs currently available on the market to treat iliac aneurysms endovascularly are simply not adequate for this surgery. With the introduction of the iliac branch graft, Cook is delivering an endovascular treatment to the Canadian market that previously was not an option," said Phil Nowell, global leader of Cook Medical's Aortic Intervention strategic business unit. "Cook is building on existing technologies designed to treat abdominal and thoracic aortic aneurysms, bringing the same level of innovation to the treatment of iliac aneurysms."

The Zenith Branch Endovascular Graft-Iliac Bifurcation, which mimics the natural iliac artery anatomy, 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 graft is completely stented to provide stability and the force needed to open the lumen of the graft during deployment. Nitinol rings located at the proximal end of the graft and within the side branch help preserve lumen patency during access, and the stainless steel Cook-Z stents provide the necessary seal of the graft to the vessel wall. Gold markers positioned along the internal iliac side of the graft aid in precise positioning.

The Zenith Branch Endovascular Graft-Iliac Bifurcation is also available in the European Union and Australia. The device is not yet available for sale in the U.S., where it is currently regulated as an investigational device.

Source
Cook Medical