Cook Medical has received FDA approval for the first drug-eluting stent to treat peripheral artery disease in the U.S.
The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding metal stent coated with the drug paclitaxel to help prevent recurring narrowing of the artery.
Drug-eluting stents are currently approved for use in coronary arteries in heart attack patients. Boston Scientific, Abbott Laboratories and Medtronic lead the market, but Cook’s is the first of its kind for peripheral arteries.
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Cook received CE Mark approval for the stent in 2009 and has launched it in more than 50 countries. It’s designed specifically to re-open the femoropopliteal artery in the thigh when the artery is narrowed or blocked as a result of PAD.
Patients with PAD have plaque buildups in the arteries that carry blood to the head, organs and limbs, limiting bloodflow and causing pain, sometimes severe enough that leg amputations or bypass graft surgeries are needed.
The FDA said that this approval expands treatment options for patients with PAD beyond existing therapies that include exercise, drug therapy, percutaneous transluminal angioplasty or bare-metal stenting.
Cook will need to conduct a five-year post-approval study of 900 patients treated with the stent to further monitor safety and efficacy, the FDA said.
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The stent will initially be available only in 80 mm lengths in 6 mm and 7 mm diameters, but Rob Lyles, global leader of the Peripheral Intervention division of Cook, said in a statement that the company plans to offer a “full suite of drug-eluting peripheral stents in the most commonly used lengths and diameters” by the end of next year.
According to the American College of Cardiology, 8 to 12 million people have peripheral artery disease. iData Research has estimated that the market for PAD devices in the U.S. will reach $5.3 billion by 2016. Medtronic and Lutonix, bought last year by C.R. Bard, have drug-coated balloons for PAD in clinical trials.
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