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Cook Zilver Stent Receives FDA Approval for Vascular Use

05 Jul 2006

BLOOMINGTON, IN, USA | Jul 05, 2006 | In a milestone achievement for the company, Cook Incorporated has received U.S. Food

and Drug Administration approval to market its Zilver Vascular Stent for use treating symptomatic vascular disease of the iliac arteries, the most common type of vascular disease.

"Peripheral vascular disease is a major health issue affecting millions of patients in the U.S. alone. Until recently, physicians have had limited options in treating vascular disease in the iliac arteries. But with this FDA approval, we now have an advanced stent design that can significantly aid patients with this condition," explained Barry Katzen, M.D., Medical Director of Baptist Cardiac and Vascular Institute, Miami, Fl. Dr. Katzen was primary investigator for the pivotal U.S. trial of the Zilver Vascular Stent.

"Cook's goal is to become the world leader in therapeutic technologies for the peripheral arteries," explained Rob Lyles, global leader of Cook's diagnostic and interventional products division. "Receiving FDA approval to sell our Zilver Vascular Stent system is a huge step for Cook toward that goal, and we look forward to building on the success we've already achieved in this area as we bring physicians another critical advance in treating peripheral vascular disease."

The indication is the first FDA approval for vascular use of Cook's Zilver stent, a self-expanding nitinol device. Cook has regulatory approval to market the stent for vascular use in more than 25 countries, including Australia, Brazil, France, Germany, the United Kingdom, India, China, Taiwan, and others. Cook's submission to the FDA was supported by data from a 20-patient pilot study and a pivotal study evaluating 151 patients at 24 U.S. 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 5 mm to 9 mm. The stent may be used to treat lesions up to 100 mm in length, according to the FDA indications.

The world's largest privately held manufacturer of medical devices with international headquarters in Bloomington, Ind., COOK(R) (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 and contract manufacturing of biopharmaceuticals, vena cava filters and other minimally invasive medical devices for radiology, cardiology, urology and women's health, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies.

SOURCE: Cook Inc.

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