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Cook to Begin First International Trial of a Paclitaxel-Eluting Stent for Peripheral Artery Disease
New Treatment Could Benefit Millions Who Suffer from Seriously Under-Diagnosed Disease BLOOMINGTON, Ind., May 3, 2005 -- With a U.S. trial already underway, Cook Group will expand its efforts to bring the world's first paclitaxel-eluting stent for peripheral artery disease (PAD) to market by launching an international clinical trial, company officials reported today. The global clinical investigation of Cook's Zilver® PTX™ Drug-Eluting Stent will enroll 760 patients at up to 50 investigational sites in Europe, Asia, Australia and Canada. "We see enormous potential to alleviate the pain and potential health risks associated with peripheral artery disease using Cook's unique combination of a self-expanding stent incorporating our polymer-free paclitaxel coating," noted Kem Hawkins, president of Cook Group Inc. "With the tremendous success achieved in reducing restenosis with paclitaxel-coated coronary stents, we hope to achieve comparable success in bringing this technology to millions of patients suffering from peripheral artery disease." The Zilver PTX Drug-Eluting Stent is a self-expanding stent made of nitinol and coated with the drug paclitaxel for insertion into the peripheral arterial system using percutaneous access. Cook has conducted extensive preclinical testing supporting the safety and performance of this device, and has an ongoing pilot study in the United States. Peripheral arterial disease affects blood vessels that lead from the heart to other areas of the body such as the legs, feet and kidneys. When the blood vessels become blocked due to fatty deposit buildup, blood circulation is restricted. Untreated, peripheral arterial disease results in pain when walking and can lead to gangrene and amputation. The trial is designed to determine the safety and effectiveness of the Zilver PTX paclitaxel-eluting stent by Cook Incorporated to clear blockages above the knee in the femoropopliteal artery (the major artery in the thigh). The stent, a small metal device that acts like a scaffold, is used to prop open the blocked arteries. But in many cases, arteries can become blocked again over time as scar tissue forms around the implanted stent. To prevent the renarrowing of the artery, the Zilver PTX is coated with paclitaxel, a drug approved for clinical use as an anti-cancer agent and used successfully with coronary stents to reduce the risk of renarrowing of the artery. Cook's Zilver PTX Drug-Eluting Vascular Stent is an investigational device not cleared by the U.S. Food and Drug Administration for sale in the United States. It is under investigation for use in the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery. The world's largest privately held manufacturer of medical devices with international headquarters in Bloomington, Ind., COOK® (www.cookmedical.com/) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has created innovative technologies for drug-eluting and bare metal stents, aortic and vascular endografts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials, vena cava filters and other minimally invasive medical devices for radiology, cardiology, urology and Ob/Gyn, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies. Contact: COOK David McCarty, 812-339-2235, ext. 2387 317-709-6941 (cell) dmccarty@cook-inc.com Source: Cook Incorporated |
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