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Cook Medical Receives Approval From Health Canada For Zenith Branch Endovascular Graft-Iliac Bifurcation

Cook Medical has received approval from Health Canada’s Medical Devices Bureau for its Zenith Branch Endovascular Graft-Iliac Bifurcation. The company claims that this product is 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 (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.”

This branch graft is bifurcated, like the iliac artery itself, with openings to connect the common iliac, side branch (internal iliac) and external iliac segments. It is based on Zenith technology, that 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, that 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. It 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 provides 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 EU and Australia. It is currently regulated as an investigational device in US and is not available for sale.