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Angiotech's Licensee, Cook Medical, Announces CE Mark Approval and European Launch of the Zilver(R) PTX(R) Stent
Date:8/11/2009

reatment for PAD when physicians in several countries completed placements of a CE Mark approved DES designed specifically to treat severe blockages in one of the largest arteries in the leg. Following the evaluation of more than 1,200 patients worldwide during its development, the Zilver PTX stent received CE Mark approval on July 24, 2009 and the first commercial implantations of the device were conducted today in a coordinated effort by physicians in the United Kingdom, Germany, France, Holland, Belgium, Sweden and Spain.

The Zilver PTX is specifically designed and CE Mark approved to treat PAD affecting the main blood vessel in the thigh, the superficial femoral artery (SFA). It is a self-expanding stent made of nitinol, a space-age 'shape memory' metal that offers unique mechanical advantages for a stent implanted in the SFA, such as the ability to resist kinking or fracturing as a result of normal movement of the leg. In addition, the Zilver PTX provides targeted delivery of paclitaxel, a drug proven to reduce restenosis, the re-narrowing of the artery with scar tissue resulting from the trauma of opening the vessel by balloon angioplasty. Originally discovered by Angiotech and licensed to Cook Medical for peripheral artery disease (and other indications) and to Boston Scientific Corporation (BSC) for coronary artery disease (and other indications), Angiotech's paclitaxel technology has been successfully and safely used in millions of patients suffering from coronary artery disease as part of BSC's TAXUS paclitaxel-eluting coronary stent program. As a result of these combined attributes, the clinical trial results suggest that the Zilver PTX stent is a durable and clinically effective peripheral stent that also has an excellent patient safety profile.

The granting of the CE Mark follows the largest clinical evaluation ever conducted for a peripheral vascular DES, led by Dr. Dake. As reported by Cook, the Zilver PTX registry involved 791 patient
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SOURCE Angiotech Pharmaceuticals, Inc.
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