Cook to Begin First International DES Trial for PAD

Cook Group announced it will be launching an international clinical trial to help bring the first paclitaxel-eluting stent for peripheral artery disease (PAD) to market.

The Zilver PTX drug-eluting stent (DES) is a self-expanding stent made of nitinol and coated with the drug paclitaxel for insertion into the peripheral arterial system using percutaneous access. Cook has conducted extensive preclinical testing supporting the safety and performance of this device, and has an ongoing pilot study in the U.S.

The global clinical investigation of Cook's Zilver PTX DES will enroll 760 patients at up to 50 investigational sites in Europe, Asia, Australia and Canada. The trial is designed to determine the safety and effectiveness of the Zilver PTX stent to clear blockages above the knee in the femoropopliteal artery (the major artery in the thigh).