Cook Medical Wins FDA Panel’s Backing for Femoral Artery Stent
Cook Medical Inc., a maker of devices for minimally invasive medical procedures, won a U.S. panel’s backing for a drug-coated stent to treat blocked femoral arteries.
The benefits of closely held Cook’s device, known as the Zilver PTX, outweigh its risks, outside advisers to the Food and Drug Administration said yesterday in an 11-0 vote, Morgan Liscinsky, an agency spokeswoman, said in an e-mail.
The device from Bloomington, Indiana-based Cook would be the first drug-coated stent approved in the U.S. to treat peripheral vascular disease in the largest artery of the upper leg. The stent could reduce leg amputations and painful bypass surgeries, the company said after winning approval for the device in Europe two years ago.
Clinical trials showed the Zilver PTX worked as well as or better than angioplasty and non-medicated stents in unclogging vessels, FDA staff said Oct. 11 in a preliminary review of the product.
The device works by propping open the femoral artery and delivering the cancer drug paclitaxel to the vessel to reduce the risk that fatty deposits will form new blockages.
Peripheral vascular devices, including stents, angioplasty balloons and synthetic grafts, generated $4.3 billion in global revenue last year and may earn $5.6 billion in 2014, according to Technavio, a market research firm in Elmhurst, Illinois.
Peripheral arterial disease affects 8 million to 12 million people in the U.S., according to the Peripheral Arterial Disease Coalition in Lakewood, Colorado. The disease can cause leg pain and raise the risks of heart attack and stroke.
Bypass surgery and angioplasty, in which a tiny balloon is inserted into the artery to clear the blockage, are among the standard treatments for the disease, according to the Mayo Clinic in Rochester, Minnesota.
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