Healthcare Industry News:  peripheral artery disease 

Devices Interventional Regulatory

 News Release - March 2, 2007

Cook Medical's Zilver Stent Approved for Vascular Use In Canada

Global Sales of Advanced Design Vascular Device up Nearly 50 Percent since Its U.S. Approval in 2006

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Cook Medical's Zilver Vascular Stent system has received approval from Health Canada's Therapeutic Products Directorate for use treating symptomatic vascular disease of the iliac arteries, the most common type of peripheral vascular disease.

"Cook is advancing as the world leader in therapeutic technologies for the treatment of peripheral artery disease," explained Rob Lyles, global leader of Cook's peripheral intervention division. "Receiving Canadian approval to sell our Zilver Vascular Stent system is yet another significant step for Cook toward that goal. We look forward to building on the success we've already achieved in this area elsewhere as we bring Canadian physicians another critical advance in treating peripheral vascular disease."

On February 5, Canadian authorities gave final approval for vascular use of Cook's Zilver stent, a self-expanding nitinol device. Cook now has regulatory approval to market the stent for vascular use in more than 25 countries, including the U.S., Australia, Europe, the United Kingdom, India, China, Taiwan, and others. Cook's submission to Canadian authorities for approval was supported by data from a 20-patient pilot study and a pivotal study evaluating 151 patients at 24 investigational sites.

Cook's Zilver Vascular Stent is indicated for use in the treatment of symptomatic vascular disease of the iliac arteries with a reference vessel diameter of 6 mm or larger. The stent may be used to treat lesions up to 100 mm in length, according to the approved indications.

About Cook Medical

Cook Medical was the first company to introduce interventional devices in the United States. Today, the company integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Cook won the prestigious Medical Device Manufacturer of the Year Award for 2006 from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.


Source: Cook Medical

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