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. -- Cook Medical's Zilver Vascular Stent system has received approval from Health Canada's Therapeutic Products Directorate Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. for use treating symptomatic vascular disease of the iliac arteries, the most common type of peripheral vascular disease Peripheral Vascular Disease Definition Peripheral vascular disease is a narrowing of blood vessels that restricts blood flow. It mostly occurs in the legs, but is sometimes seen in the arms. . "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 according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. 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 aortic pertaining to or emanating from the aorta. See also aortic arch. aortic aneurysm occurs most often in dogs, where it is caused by Spirocerca lupi larvae, turkeys and primates, causing dyspnea, cyanosis and coughing. intervention; cardiology; critical care medicine; gastroenterology gastroenterology Medical specialty dealing with digestion and the digestive system. In the 17th century Jan Baptista van Helmont conducted the first scientific studies in the field; William Beaumont published his own observations in 1833. ; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology urology Medical specialty dealing with the urinary system and male reproductive organs. It traces its origin to medieval lithologists, itinerant healers who specialized in surgical removal of bladder stones. ; and assisted reproductive technology Assisted reproductive technology (ART) is a general term referring to methods used to achieve pregnancy by artificial or partially artificial means. It is reproductive technology used in infertility treatment, which is the only application routinely used today of , 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. |
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