Medtronic gets FDA approval for Endeavor, first new drug-coated stent in 4 years
WASHINGTON (AP) -- Medtronic on Friday received federal approval to sell its drug-coated stent, the first to hit the U.S. market since safety concerns sank their popularity two years ago.
The Food and Drug Administration said it cleared the company's Endeavor stent for use in patients with clogged arteries. Medtronic said it expects to ship 100,000 units to hospitals in February.
Endeavor is one of a new generation of stents the industry hopes can rejuvenate U.S. demand for the drug-oozing devices, sales of which plummeted to $2 billion last year, down from a peak of $3.1 billion in 2005.
Stents are tiny, mesh-wire tubes that prop open arteries after they have been surgically cleared of fatty plaque. They became one of the most lucrative medical devices in modern history after companies began adding drug coatings to stents in 2003 to prevent blood clotting.
An estimated 6 million people worldwide have had one implanted.
Shares of Medtronic rose $1.35, or 2.9 percent, to $47.85 Friday.
A series of studies in 2006 showed that months after they're implanted, stent coatings have the potential to increase the risk of life-threatening blood clots unless patients continue to take anti-clotting drugs. Medical societies, such as the American College of Cardiology, urge patients to continue taking the drugs for at least a year after implantation.
In late 2006, a panel of federal advisers said that the majority of patients with the drug-coated stents have an increased risk of heart attack and death, though it's unclear whether their poor health or the drug coatings are to blame.
The percentage of stent patients receiving drug-coated versions versus the older, bare-metal models has fallen to an estimate 65 percent, from more than 80 percent, before 2006.
The new offering from Minneapolis-based Medtronic will compete with older stents from Johnson & Johnson and Boston Scientific Corp. -- two companies that cut thousands of jobs in recent months, partially because of lower stent sales.
And there's been more bad news for companies that sell stents as recently as last week. A study in the New England Journal of Medicine showed patients who underwent bypass surgery had fewer heart attacks than those who had stents implanted. The study dimmed hopes that less intrusive stenting would prove just as safe as surgery for people with clogged arteries.
Cleveland Clinic cardiologist Deepak Bhatt said it will probably be years before enough data is collected to definitively say whether one stent outperforms others.
"There's so many ways to slice and dice data that any one of these companies could probably find a way to claim superiority," said Bhatt, who directs Cleveland Clinic's cardiovascular center. "But the availability of new drug-eluting stents expands options for doctors and patients, which is always a good thing."
But not for Johnson & Johnson and Boston Scientific Inc, which account for 45 percent and 55 percent, respectively, of the U.S. market. The Endeavor is expected to capture about 20 percent of that space in 2008, according to projections from Morgan Stanley analyst Glenn Reicin.
(Copyright 2008 by The Associated Press. All Rights Reserved.)