First U.S. Drug-Eluting Stent Trial To Treat Peripheral Arterial Disease Enrolls First Patient At Stanford University Medical Center.

STANFORD, Calif. -- New Treatment Could Benefit Millions Who Suffer From Seriously Under-Diagnosed Disease

The first patient was treated Monday at Stanford University Medical Center in a landmark clinical trial evaluating a drug-coated stent from Cook Incorporated 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, which have shown clinical success in treating coronary artery disease, can have similar benefits in treating arteries outside the heart. The elderly female patient was treated by a team of doctors led by Michael D. Dake, M.D., Professor and Chairman of the Department of Radiology at the University of Virginia Health System and national principal investigator, and Daniel Sze, M.D., Associate Professor of Radiology at Stanford University Medical Center and principal investigator for the trial at Stanford.

"Drug-eluting stents that combine a metal scaffold with a drug were first applied in the heart and the results have been phenomenal," Dake said. "Currently, drug-eluting stents are the primary therapy for obstruction in the coronary circulation. And it is hoped similar technology, used in the legs, will help those who suffer from peripheral arterial disease.

"The patient treated Monday with the Zilver PTX stent underwent surgical aortoilliac revascularization previously, but still experienced pain after walking one-and-a-half blocks," Dake said. "We will eagerly anticipate her outcome as we follow her in the trial."

Peripheral arterial disease affects blood vessels that lead from the heart to other areas of the body such as the legs, feet and kidneys. When the blood vessels become blocked due to fatty deposit buildup, blood circulation is restricted. Untreated, peripheral arterial disease results in pain when walking and can lead to gangrene and amputation.

The trial is designed to determine the safety and effectiveness of the Zilver(R) PTX(TM) paclitaxel-eluting stent by Cook Incorporated to clear blockages above the knee in the femoropopliteal artery (the major artery in the thigh). The stent, a small metal device that acts like a scaffold, is used to prop open the blocked arteries. But in many cases, arteries can become blocked again over time as scar tissue forms around the implanted stent. To prevent the renarrowing of the artery, the Zilver PTX is coated with paclitaxel, a drug approved for clinical use as an anti-cancer agent and used successfully with coronary stents to reduce the risk of renarrowing of the 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.

The Zilver PTX stent is an investigational device not approved for sale in the United States.

Peripheral arterial disease is seriously under-diagnosed and can be a predictor of an increased risk of cardiovascular disease or stroke. Risk factors for PAD include smoking, diabetes and high blood pressure.

Stanford University Medical Center integrates research, medical education and patient care at its three institutions - Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital. For more information, please visit the Office of Communication & Public Affairs site at http://mednews.stanford.edu.

The world's largest privately held medical device manufacturer with international headquarters in Bloomington, Ind., COOK(R) (www.cookmedical.com) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has created innovative technologies for stents and stent-grafts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials, vena cava filters, implanted cardiac lead extraction equipment and other minimally invasive medical devices.