A Medical Device Daily

Two patients treated by doctors in Brazil for debilitating leg pain became the first patients outside the U.S., in late June, to receive a paclitaxel-coated stent to treat peripheral arterial disease (PAD). The two older men were walking without pain and released from Casa de Saude Sao Jose hospital the day after they received Zilver PTX drug-eluting vascular stent from Cook (Bloomington, Indiana) as part of a worldwide trial to determine whether drug-eluting stents (DESs) are as effective in treating PAD as they are in treating heart disease.

Cook’s Zilver PTX Drug-Eluting Vascular Stent is under investigation for the use in the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery. The Zilver PTX trial is being conducted initially in 31 U.S. medical facilities and will enroll 60 patients. In May, Cook expanded its trial to include up to 760 patients at more than 50 sites in Europe, Asia, Australia, Canada and Latin America.

The study compares the safety and effectiveness of the drug-eluting stent to standard PAD interventions, and is the first trial to test if a paclitaxel-eluting DES device can be used to treat PAD, Cook said.

Cook holds a co-exclusive license from Angiotech Pharmaceuticals (Vancouver, British Columbia) for the use of paclitaxel in the peripheral vascular and also for gastrointestinal use.