A bare metal stent (above) is coated with paclitaxel, a drug that is released in the vessel (below) to help prevent renarrowing of the artery.

Drug-coated stents have made a remarkable impact on the treatment of heart disease. These devices - small metal "scaffolds" that hold open blocked arteries - are coated with medicines that help keep arteries open for extended periods. It's believed that this same technology can help patients who suffer from PAD.

Drug-coated stents have been available for the treatment of heart disease in the United States since April 2003, when the FDA approved two new coronary drug-coated stents. It's believed that drug-coated stents may become the standard of care for many cardiovascular patients.

Benefits
What are the benefits of drug-coated stents? In many cases, patients who have been treated with bare metal stents (without any drug coating) experience a renarrowing of the arteries over time. This happens when cells grow around the stent - essentially creating scar tissue - and cause the blood vessel to narrow again. In fact, statistics show that up to 40 percent of patients will suffer from a renarrowing of arteries over time, making it necessary to repeat the procedure.

The newest advancement is to coat a stent with a medicine that, released over time, can often help prevent the renarrowing - or scarring - of the arteries.

A new approach
It's this technology that Cook Incorporated, manufacturer of many of the world's best-selling minimally invasive medical device technologies for the treatment of vascular diseases, has used in the development of the Zilver® PTX™ Drug-Eluting Stent. Cook's Zilver stent is coated with paclitaxel, a drug approved for use as an anti-cancer agent and used successfully with coronary stents to reduce the risk of renarrowing of the coronary arteries.

Cook is investigating the safety and effectiveness of this new device to treat blockages above the knee in the major artery in the thigh (the femoropopliteal artery). This will be a multinational clinical trial performed at 31 investigative centers in the United States and will also include medical centers in Europe, Australia, Latin American, Asia and Canada.

How it would work
In the Zilver® PTX™ Drug-Eluting Stent Trial, a surgeon makes an incision in the groin and guides a stent to the narrowed artery with a catheter. The stent is deployed and expands to stay in place to help keep the artery open after the catheter is withdrawn. The stent is coated with the drug paclitaxel, which is released into the vessel to help prevent the renarrowing of the artery over time.