FDA approves Cook's Zilver PTX drug-eluting peripheral stent
Published on November 16, 2012 at 11:51 PM
Angiotech Pharmaceuticals, Inc. ("Angiotech") announced that its partner Cook Medical, Inc. ("Cook") received approval on November 15, 2012 from the U.S. Food and Drug Administration ("FDA") to market and sell the proprietary Zilver® PTX® drug-eluting peripheral stent, adding the United States to the list of over 50 markets, including the European Union and Japan, where Zilver PTX is approved for sale. Zilver PTX is the first drug-eluting stent indicated for use in peripheral artery disease approved by the FDA.
"We wish to offer our congratulations to Cook Medical on this important milestone in the development and commercialization of Zilver PTX," said Thomas Bailey, President and CEO of Angiotech. "The use of paclitaxel to treat restenosis is Angiotech's founding technology platform, and we are excited to see this technology further developed and commercialized by Cook in a truly novel product for the treatment of peripheral vascular disease."
Cook's Zilver PTX peripheral stent incorporates Angiotech's proprietary paclitaxel technology, which was first commercialized by Angiotech's partner Boston Scientific Corporation ("BSC") in the TAXUS® stent platform for the treatment of coronary artery disease. Paclitaxel eluting stents have been shown in multiple clinical studies, in both coronary and peripheral vascular disease, to reduce rates of repeat blockages, or restenosis, following initial implantation of a stent in diseased vessels.
Data from Cook's pivotal clinical trial indicate that eight out of 10 patients treated with Zilver PTX still had open arteries (primary patency) after one year, as compared to only three out of 10 patients treated with balloon angioplasty alone. In addition, patients who received a bare metal stent required more than twice as many reintervention procedures to reopen the treated vessel as compared to patients who received Zilver PTX.
Cook and BSC originally licensed Angiotech's proprietary paclitaxel technology in 1997. Angiotech receives royalties from Cook derived from Cook's sales of Zilver PTX.
Angiotech Pharmaceuticals, Inc.