Medtronic wins FDA approval for drug-coated stent

CHICAGO (Reuters) - U.S. health regulators on Friday approved Medtronic Inc's new drug-eluting heart stent, the first heart device of its kind to win U.S. approval in about 4 years.

Medtronic will join Johnson & Johnson and Boston Scientific Corp as the manufacturers of the only such heart devices -- which pop open diseased heart arteries and deliver medicine to keep them from reclosing -- approved in the

U.S.

But the tiny wire mesh tubular device that Medtronic calls Endeavor may face a far less welcoming reception from physicians than its predecessors as it enters a market clouded by controversy.

The market for the drug-coated variety of stents has fallen from a peak of around $6 billion in recent years over safety concerns about blood clots forming long after implantation in some patients.

Medtronic estimates the global market for the devices now stands at about $4 billion.

The Minneapolis-based company, which also makes pacemakers and insulin pumps, is billing Endeavor as a safer stent.

An FDA advisory panel in October recommended approval of the device, saying it appeared safe and effective based on current data. The panel also recommended the company commit to a large follow-up study to monitor the blood clotting issue.

Drug-coated stents were hailed as a major medical advance in 2003, when J&J's device was approved and the newer generation rapidly replaced cheaper and older bare-metal stents in many uses. The popularity stemmed from the drug coating's ability to cut the incidence of reclogging.

But the emergence of an increased risk of late-stage blood clotting, known as thrombosis, led some doctors to switch back to bare-metal stents.

Still another large study, released late last year, suggested that patients who received drug-coated stents were not more likely to die or suffer heart attacks than those who got bare-metal versions, fanning the debate further.

Should clotting, in fact, be less of an issue, then Endeavor might have trouble finding a niche, according to Debbie Wang, a Morningstar analyst.

"That kind of cuts the leg out from under Medtronic's whole marketing platform, suggesting that this is the safer stent," she said. "I just don't know there is really a nice niche for the Endeavor stent to slide into."

But, she added, having a new device is going to help Medtronic.

"Interventional cardiologists tend to be gadget junkies. I'm sure they will be a number of them who are eager to try out this new stent," she said.

Medtronic said it will begin selling the Endeavor stent immediately and will ship some 100,000 to U.S. hospitals in the next 30 days.

Abbott Laboratories Inc is awaiting an FDA decision for its drug-coated stent, Xience. Analysts expect approval during the second quarter.

Mike Weinstein, an analyst with JP Morgan, reckons Medtronic's market share will likely approach 20 percent in the interim period before Abbott's Xience is launched, slipping to the mid-teens thereafter.

Medtronic shares were up $1.08 or 2.3 percent to $47.65 on the New York Stock Exchange.

(Additional reporting by Kim Dixon in Washington, editing by Gerald E. McCormick)