Zilver PTX Paclitaxel-Eluting Stent Approved
Angiotech announced that its partner Cook Medical received approval from the FDA for Zilver PTX drug-eluting peripheral stent. Zilver PTX is the first FDA-approved drug-eluting stent indicated for use in peripheral artery disease.
Zilver PTX peripheral stent utilizes Angiotech's proprietary paclitaxel technology, which was first seen in the Taxus stent (Boston Scientific) 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 in diseased vessels.
Study results from Cook's pivotal trial showed that 8 out of 10 patients treated with Zilver PTX still had open arteries (primary patency) after one year, as compared to only 3 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 vessel as compared to patients who received Zilver PTX.
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