Cook Medical and Angiotech Pharmaceuticals received CE Mark approval Monday for their polymer-free Zilver PTX drug-eluting peripheral stent to treat blockages in the legs caused by peripheral arterial disease (PAD).
The Bjaeverskov, Denmark-based Cook said its Zilver PTX is designed and approved to treat PAD affecting the main blood vessel in the thigh, the superficial femoral artery (SFA). It is a self-expanding stent made of nitinol.
The CE Mark is based on a large clinical trial for a peripheral stent, led by Michael Dake, MD, professor in the department of cardiothoracic surgery at Stanford University Medical School in Stanford, Calif., and medical director of the Cath/Angio Laboratories at Stanford University Medical Center in Palo Alto, Calif. The data published in the Zilver PTX registry involved 791 patients from Europe, Russia, Canada and South Korea. Only 8 percent of patients with de novo lesions needed a revascularization to reopen the artery in the first 12 months -- a rate significantly surpassing existing treatments for PAD in the SFA, such as balloon angioplasty and bare metal stents.
Cook has licensed the product from the Vancouver, British Columbia-based Angiotech for use against peripheral artery disease, and the Natick, Mass.-based Boston Scientic has the rights to the product in coronary artery disease.
PAD is estimated to affect 27 million individuals in Europe and North America, including eight to 12 million Americans.