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February 29, 2012
Cook's Zilver PTX Stent Approved in Japan
March 1, 2012—Cook Medical (Bloomington, IN) announced that it has received approval from Japan’s Pharmaceuticals and Medical Devices Agency to sell the Zilver PTX paclitaxel-eluting peripheral stent, which is indicated for treating peripheral arterial disease in the superficial femoral artery.
According to Cook, the Zilver PTX combines mechanical support via stenting with the drug paclitaxel to reduce the risk of restenosis. Data from the company’s multinational clinical trial conducted in Japan, the United States, and Germany were used to support regulatory submissions for Zilver PTX in Japan, the United States, and Europe.
The device received CE Mark approval in August 2009 and is available in more than 45 countries. In the United States, it is under review by the US Food and Drug Administration and is not available for sale, advised the company.
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