Cook Incorporated

July 11, 2005 15:26 ET

News from Cook: Two Patients Treated in First International Case Testing Drug-Eluting Stents To Treat Peripheral Arterial Disease

BLOOMINGTON, Ind.--(CCNMatthews - Jul 11, 2005) -

On June 24, two patients treated by doctors in Brazil for debilitating leg pain became the first patients outside the United States to receive a paclitaxel-coated stent to treat peripheral arterial disease. The two elderly gentlemen were walking without pain and released from Casa de Saude Sao Jose hospital the day after they received Cook's Zilver® PTX™ drug-eluting vascular stent as part of a worldwide trial to determine whether drug-eluting stents are as effective in treating peripheral arterial disease as they are in treating heart disease.

Marcelo Ferreira, M.D., vascular surgeon at Casa de Saude Sao Jose, implanted Zilver PTX paclitaxel-eluting stents in two elderly men in a procedure that was broadcast live during the Simposio Internacional de Techniques Endovascular in Rio de Janeiro. Each patient received four stents in his femoropopliteal artery, the major artery in the thigh.

Cook's Zilver PTX trial is the first trial ever to test whether paclitaxel-eluting stents can be used to successfully treat peripheral arterial disease, a seriously under-diagnosed disorder affecting up to 20 percent of the adult population worldwide. Drug-eluting stents have been used with extraordinary success in treating patients with heart disease.

"The patients had a very difficult time walking before the treatment, but were walking without pain shortly after the implant," Ferreira said. "We expect the paclitaxel-coated stent to work for a long time in keeping the arteries clear from restenosis, or a blockage of the arteries over time."

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. PAD affects up to 10 million Americans and 27 million people in North America and Europe every year.

While bare metal stents have been used to treat peripheral arterial disease, in many cases patients' arteries become clogged again over time as scar tissue forms around the implanted stent. To prevent this renarrowing of the patient's 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.

Cook's clinical trial started in March, after the first patient was treated with the Zilver PTX device at Stanford University in California. The Zilver PTX trial is being conducted initially in 31 U.S. medical facilities and will enroll 60 patients, with an expanded trial likely, pending further FDA review. In May, Cook expanded its trial to include up to 760 patients at more than 50 sites in Europe, Asia, Australia, Canada and Latin America. The study compares the safety and effectiveness of the drug-eluting stent to standard PAD interventions.

"The techniques and technologies for treating patients with this often crippling, painful disease have advanced, but there's much more we can do," said Rob Lyles, global leader of Cook's Diagnostic and Interventional products division, which developed the Zilver PTX stent. "We are optimistic that drug eluting stents like the Zilver PTX can further advance the treatment of peripheral arterial disease and can improve patient outcomes."

Cook's Zilver PTX Drug-Eluting Vascular Stent is an investigational device not approved for sale in the United States. It is under investigation for the use in the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery.

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

The world's largest privately held medical device manufacturer with international headquarters in Bloomington, Ind., COOK® (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.

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