FDA advisers back Cook stent for leg arteries
(Reuters) - U.S. health advisers on Thursday unanimously backed a new Cook Medical stent coated with a common cancer-fighting drug to treat clogged arteries in the thighs.
A panel of outside experts to the Food and Drug Administration said the Zilver PTX stent was safe and effective for keeping blood vessels above the knee free from plaque.
The device could become the first drug-coated stent to treat peripheral arteries in the U.S. market if the FDA follows the recommendation of the panel, which it is not required to do.
Privately-held Cook Medical, based in Bloomington, Indiana, competes against device makers such as Boston Scientific and Covidien, which also make leg stents, in a stent market estimated at $5 billion worldwide.
Stents are tiny mesh-like tubes used to prop open arteries that have been cleared of blockages from plaque, a build-up of cholesterol, fatty deposits and scar tissue.
"This hasn't really been about bringing a product to market; it's been about bringing a new option to patients," David Timlin, distinguished regulatory affairs advisor at Medtronic Surgical Technologies and the industry representative on the panel, said at the meeting, which was webcast.
"It's just a prime example of how things should work, especially in an environment where industry and the FDA are sometimes adversarial," he said, echoing generally glowing reviews from panel members.
The most commonly used drug-coated stents are placed in heart arteries following angioplasty procedures, when doctors open clogged arteries with an inflated balloon.
The Cook Medical stent is coated with paclitaxel, an anti-cancer drug. The drug is used to help prevent re-clogging of the artery by inhibiting the growth of scar tissue.
The device was approved for sale in Europe in 2009.
The Zilver PTX stent is meant to treat peripheral arterialdisease, which according to the company affects about 30 million people a year. The disease develops when arteries outside the heart build up plaque, causing them to narrow and restrict blood flow.
Patients with the disease may have pain when walking, sores or ulcers, or weakness in the legs. Total loss of circulation can lead to gangrene and limb amputation, although that is rare.