Cook files PMA for drug-eluting PAD stent

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Cook Medical has submitted its pre-market approval (PMA) application to the FDA for its polymer-free Zilver PTX drug-eluting peripheral stent.

Intended for use in patients with peripheral arterial disease (PAD) in the superficial femoral artery, Zilver PTX is a self-expanding, nitinol stent that uses a polymer-free technology to deliver a locally therapeutic dose of paclitaxel, according to the Bloomington, Ind.-based company.

Cook said PMA submission includes data from the randomized portion of the ongoing Zilver PTX clinical trial, which is a single-arm registry and a randomized study involving 1,276 total patients including diabetics, symptomatic patients and those with complex lesions. Patency data from the single-arm study was reported at 86.2 percent at 12 months at EuroPCR last month.