Cook files PMA for drug-eluting PAD stent
Cook Medical has submitted its pre-market approval (PMA) application to the FDA for its polymer-free ZilverPTX 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.
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.