Cook Medical completes enrollment for new drug-eluting peripheral stent

The 420 patients enrolled in Cook’s randomized trial of its Zilver PTX
drug-eluting peripheral stent include peripheral arterial disease patients treated in Germany, the US and Japan.

The Zilver PTX trial was designed to determine whether the combination of Cook’s Zilver stent and a paclitaxel coating will keep peripheral arteries, specifically the superficial femoral artery, open over time.

Preliminary findings revealed clinical improvement in patients treated with the Zilver PTX – excellent stent durability, high rates of event-free survival and freedom from target lesion revascularization.

Cook has enrolled an additional 780 patients in the EU, Canada, and Korea in a clinical registry to evaluate the safety of the Zilver PTX device. Those data have been used for a submission in Europe for CE mark approval to market the device there, with additional regulatory submissions pending in additional markets. In addition, the stent already has regulatory approval for commercial use in New Zealand, Hong Kong and Singapore, where it has been used to treat patients suffering with peripheral arterial disease.

Cook Medical’s Zilver PTX is said to be a self-expanding nitinol stent, which uses a proprietary, polymer-free technology to coat the device with paclitaxel, an antiproliferative drug that has been used successfully to reduce the risk of renarrowing of arteries following angioplasty in coronary disease patients.

Rob Lyles, global leader of Cook Medical’s peripheral intervention business unit, said: “Based on preliminary results, we anticipate that the Zilver PTX Stent will be found safe and effective by the world’s medical regulatory bodies, and we expect to put this uniquely advanced medical therapy into the hands of the world’s physicians in the near future.”