Bloomington-based Cook Medical won approval from the U.S. Food and Drug Administration for its drug-coated stent designed to prop open arteries outside the heart and prevent inflammation that might close them again.
The product, called the Zilver PTX Drug-Eluting Stent, already is approved in 50 other markets, including Australia, Japan and Europe. But the United States accounts for roughly 40 percent of the global market in stents for peripheral arteries, so U.S. approval is key for Cook’s revenue from the Zilver product.
Worldwide, peripheral stents had about $2 billion in sales in 2010, according to market research by various firms pulled together by Inspire MD, an Israel-based company developing technologies for coronary and peripheral stents. Industry analysts expect peripheral stents to grow rapidly to about $3.2 billion by the end of next year.
Peripheral artery disease, or PAD, typically occurs in patients’ legs, and is more common in the increasing number of patients suffering from obesity or diabetes. Stents are flexible metal tubes that hold open a section of an artery.
Current treatment options are not ideal. Within a year of diagnosis, as many as 40 percent of U.S. patients end up having an amputation. And according to Cook, 70 percent of patients whose peripheral arteries are propped open through angioplasty see their arteries close again within a year.
Cook’s Zilver stent is coated with the drug paclitaxel—the same as used on many coronary artery stents—which dampens growth of cells in artery walls. The growth can re-close an artery with a stent in it.
In clinical trials, eight of 10 Zilver patients still had their arteries open a year later. Also, half as many Zilver patients needed to come back for a new surgical procedure as did patients receiving a bare metal stent.
“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,” Dr. Gary Ansel, director of the Center for Critical Limb Care at Riverside Methodist Hospital in Columbus, Ohio, said in a statement released by Cook. “Drug-eluting stents such as Zilver PTX will move quickly, in my opinion, to become the standard of care for PAD patients worldwide.”
The FDA will require Cook to conduct another five-year clinical trial, involving 900 patients, to further monitor safety and efficacy.
While Cook’s is the first drug-coated stent for peripheral arteries to be approved by the FDA, it is likely to see fierce competition.
Minnesota-based Medtronic Inc. has been testing a drug-coated balloon that would prop open arteries, cut down re-closing and yet leave no stent behind.
Also, Illinois-based Abbott Laboratories has been testing its Xpert stent as a treatment for peripheral artery disease.
Still, Rob Lyles, global leader of Cook’s perhperhal intervention division, expressed confidence.
“No other company can match Cook’s commitment to this technology,” he said in a prepared statement, “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.”