First Patient Enrolled in U.S. DES Trial to Treat PAD

The first patient was treated at Stanford University Medical Center in a clinical trial evaluating a drug-coated stent from Cook for peripheral arterial disease (PAD), a serious medical condition that affects more than 10 million Americans each year.

The trial is the first U.S. trial ever to test whether drug-eluting stents (DESs), which have shown clinical success in treating coronary artery disease, can have similar benefits in treating arteries outside the heart. The trial is designed to determine the safety and effectiveness of the Zilver PTX paclitaxel-eluting stent by Cook to clear blockages above the knee in the femoropopliteal artery.

The Zilver PTX trial is being conducted initially in 10 U.S. medical facilities and will enroll 60 patients, with an expanded trial likely pending further FDA review. The study compares the safety and effectiveness of the drug-eluting stent to standard PAD interventions. Cook hopes to complete enrollment in the pilot study by the end of 2005 and complete enrollment in the pivotal study by the end of 2006. The trial data will be used to apply for FDA approval of the device for U.S. sale.