Zilver PTX stent from Cook Medical gains CE mark


In a breakthrough development offering a truly modern, highly effective medical treatment for peripheral artery disease, physicians in the UK recently completed patient implants of the first CE mark-approved drug-eluting stent designed specifically to treat severe blockages in the challenging and largest artery in the leg.

Approval of the Zilver PTX Drug-Eluting Peripheral Stent from Cook Medical represents a global landmark in effective peripheral intervention for treating peripheral artery disease.

Cook’s Zilver PTX is specifically designed and approved to treat peripheral artery disease affecting the main blood vessel in the thigh, the superficial femoral artery. It is a self-expanding stent made of nitinol, a space-age ‘shape memory’ metal that offers unique mechanical advantages for a stent in the superficial femoral artery. By eliminating the need for a polymer or plasticising agent to hold the drug to the stent body, Cook has created a medical breakthrough that solves two key problems. First, it allows targeted delivery of a drug (paclitaxel) proven to reduce the renarrowing of arteries opened using balloon angioplasty. Second, by eliminating the need for a polymer, which was left behind on the body of earlier drug-eluting stents after the drug dissolved into the surrounding tissues, Zilver PTX avoids the potential patient risks posed by leaving a permanent foreign, plastic substance in the body. In addition, the Zilver stent was proven during its clinical trial to be the most durable peripheral stent available, suggesting even greater patient safety, according to the clinical trial data.

The CE mark follows the world’s largest-ever clinical trial for a peripheral stent, led by Michael Dake, professor in the Department of Cardiothoracic Surgery at Stanford University Medical School and medical director of the Cath/Angio Laboratories at Stanford University Medical Center, Palo Alto, California. The data published in the Zilver PTX registry involved 791 patients from Europe, Russia, Canada, and Korea and demonstrated highly positive results.