Bloomington, Ind. – Cook Incorporated will soon begin the first U.S. clinical trial of a drug-coated stent for a peripheral (non-coronary) artery, company officials announced today. The study will examine whether drug-coated stents, which have shown clinical success in treating coronary artery disease, can have similar benefits in treating peripheral vascular disease.

Cook’s trial is the first clinical investigation approved by the U.S. Food and Drug Administration to study the effectiveness of a drug-eluting stent for a peripheral artery. The trial will investigate the use of the Zilver® PTX paclitaxel-eluting stent in the above-the-knee femoropopliteal artery, Cook officials reported. It will be conducted initially at 10 U.S. medical facilities and will enroll 60 patients, with an expanded trial likely pending further FDA review. The company expects to enroll its first patient in the trial in September.

“This is one of the most anticipated trials in years,” said the trial’s national principal investigator Michael D. Dake, M.D., chief of cardiovascular and interventional radiology at Stanford University School of Medicine. “There is tremendous investigator enthusiasm for the trial to determine if benefits comparable to those achieved in patients with coronary lesions can be obtained by translating similar drug-eluting stent technology to symptomatic individuals with peripheral arterial disease.”

“A coronary stent coated with paclitaxel is now the top-selling device of its kind for patients with coronary artery disease, and we hope our trial will help Cook determine whether a similar drug-eluting stent can demonstrate comparably positive clinical results for patients with peripheral vascular disease,” noted Kem Hawkins, president and chief executive officer of Cook Incorporated.

Like the arteries feeding the heart muscle, arteries in other areas of the body can narrow due to vascular disease and become partially or fully blocked, a condition called stenosis. Using a small balloon inflated inside the artery at the site of the blockage, physicians can open many blockages in a procedure called an angioplasty. But, much like coronary arteries can redevelop health-threatening blockages in a process called restenosis, peripheral arteries also may close again months or years following angioplasty.

Stents, small metal devices that act like scaffolds to prop open blocked arteries, have become enormously successful at reducing the rate of restenosis in both coronary and peripheral arteries. But even these advanced devices sometimes cannot hold open an artery as it forms new blockages. For heart patients, the advent of stents coated with drugs to retard or eliminate the metabolic processes that cause blockages to return has proven enormously successful, making these devices among the great medical success stories of recent years.

The trial will examine whether the Zilver PTX self-expanding vascular stent coated with an anti-tumor agent called paclitaxel can provide clinical benefit to patients receiving stents in the femoropopliteal artery, Cook officials explained. The Zilver PTX Peripheral Stent is an investigational device not approved for sale in the United States.

With international headquarters in Bloomington, Ind., privately held COOK® (www.cookgroup.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 and other minimally invasive medical devices for radiology, cardiology, urology and OBN/GYN, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies.