VANCOUVER, Sept. 10 /PRNewswire-FirstCall/ -- Angiotech Pharmaceuticals, Inc. ("Angiotech") , a global specialty pharmaceutical and medical device company, today announced that its corporate partner, Cook Medical, has completed enrollment in the first international clinical trial of a drug-eluting stent designed to treat arterial blockages outside the coronary arteries. The 420 patients enrolled in Cook's randomized trial of its Zilver PTX Drug Eluting Peripheral Stent include peripheral arterial disease (PAD) patients treated in Germany, the United States and Japan.
"We would like to congratulate our partner Cook on completing enrollment in this pioneering clinical program and for completing their CE Mark submission in Europe," said Dr. Bill Hunter, President and CEO of Angiotech. "The completion of this stage of the program demonstrates the continued strength and breadth of our paclitaxel franchise, and brings us closer to offering the same drug-eluting stent technology to patients with peripheral artery disease that has benefited millions of coronary artery disease patients to date."
In many cases, PAD patients who have been treated with balloon angioplasty and stenting experience restenosis, or renarrowing of the arteries, over time and must undergo more invasive treatment such as bypass surgery to restore blood flow to key arteries. The Zilver PTX trial (http://www.zilverptxtrial.com/) was designed to determine whether the combination of Cook's Zilver stent and the drug paclitaxel will keep peripheral arteries, specifically the superficial femoral artery (SFA), open over time.
Cook already has enrolled 780 patients in the European Union, Canada, and Korea in a clinical registry to evaluate the safety of the Zilver PTX device. Those data have been used for a submission in Europe for CE Mark approval to market the device there, with additional regulatory submissions pending in additional markets. In addition, Zilver PTX stent already has regulatory approval for commercial use in New Zealand, Hong Kong and Singapore, where it has been used to treat patients suffering from PAD.
Cook licenses the rights to use paclitaxel with peripheral stents and other non-coronary medical devices from Angiotech. Under the terms of its 1997 license agreement with Cook, Angiotech is entitled to receive royalty payments upon the commercial sale of paclitaxel-eluting peripheral vascular stent products, including the Zilver PTX.
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About Angiotech
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company with over 1,500 dedicated employees. Angiotech discovers, develops and markets innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury. To find out more about Angiotech , please visit our website at http://www.angiotech.com/.
