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FDA Approves First Drug-Eluting Stent in U.S. for Peripheral Arterial Disease

Manufacturing Group | November 22, 2012

Cook Medical's Zilver PTX drug-eluting peripheral stent includes a paclitaxel drug to prevent renarrowing of the artery.

Cook Medical has received U.S. Food and Drug Administration (FDA) marketing approval for the first devices in its Zilver PTX Drug-Eluting Peripheral Stent portfolio, according to company officials. It’s the first time the FDA has approved a drug-eluting stent to treat blockages in a peripheral artery.

“This approval marks the start of Cook’s program to bring the benefits of drug elution to U.S. physicians treating the peripheral arteries,” says Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention division. “No other company can match Cook’s commitment to this technology, and by the end of 2013, we expect to have a full suite of drug-eluting peripheral stents in the most commonly used lengths and diameters available to U.S. physicians.”

The Zilver PTX Drug-Eluting Stent is intended to treat peripheral arterial disease (PAD) in the superficial femoral artery (SFA).

In order to supply as many physicians as possible with this new technology, Cook is making Zilver PTX available initially in 80mm lengths in 6mm and 7mm diameters. The products indications for use also allow two Zilver PTX 80mm stents to be overlapped to treat longer lesions up to 140mm. The FDA approval also includes 40mm and 60mm lengths, which will be introduced to the United States early in 2013. Cook expects to receive regulatory approval for 120mm length stents in both diameters next year.

Data from Cook’s pivotal clinical trial indicate:

--Eight out of ten patients treated with Zilver PTX still had open arteries (primary patency) after one year. That compares to only three out of 10 patients treated with angioplasty alone.
--Patients who received a bare metal stent required more than twice as many reintervention procedures to reopen the SFA as patients who received Zilver PTX.2.

“After conducting the largest randomized controlled study of peripheral stenting ever undertaken, we now see remarkable results in patients treated with Zilver PTX,” says Michael Dake, M.D., a professor in the Department of Cardiothoracic Surgery at Stanford University School of Medicine and medical director of the Cath/Angio Laboratories at Stanford Medical Center, Palo Alto, CA.

“With this approval, treating PAD in the U.S. will begin to undergo the same revolution that drug elution did for treating coronary artery disease,” adds Gary Ansel, M.D., director for the Center for Critical Limb Care at Riverside Methodist Hospital in Columbus, OH, and an assistant clinical professor of medicine in the Department of Internal Medicine at the University of Toledo Medical Center in Toledo, OH. “Drug-eluting stents such as Zilver PTX will move quickly, in my opinion, to become the standard of care for PAD patients worldwide.”

Cook’s Zilver PTX stent is already approved for sale in more than 50 markets, including the European Union, Japan, Brazil and most of South America, Australia, New Zealand, and Taiwan. The device is being introduced to the U.S. market in a five-step process designed to make this technology available to as many patients as possible initially.

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