FDA approves Abbott Labs' new stent

Abbott Laboratories won U.S. approval for its Xience heart stent, a product analysts predict will lead a $4 billion-a-year market for the artery-opening devices.

Xience, a drug-coated mesh sleeve used to prop open clogged blood vessels, was cleared for marketing by the Food and Drug Administration, the company said Wednesday in a statement.

Sales will begin immediately, Abbott said.

Easier to implant than rival stents and superior in clinical trials, Xience and a version licensed to Boston Scientific Inc. called Promus could generate as much as $2 billion in annual sales by 2010, according to analyst estimates.

For Abbott, U.S. approval brings the company closer to a payoff on its $4.1 billion purchase of Guidant Corporation's stent division in 2006.

"It's going to be a very respectable product for them, certainly for the next year or so, because you're getting a big shot of revenue," said Bruce Nudell, a UBS analyst in New York. "Short-term if this product does well, then it will be a big deal. It will help the stock."

Abbott rose as much as 2.1 percent in extended trading after closing at $54.24, up 3 cents, in New York Stock Exchange composite trading.

More recent research has found no dropoff in safety, and sales rebounded this year.

The FDA ordered the company to follow 5,000 patients for at least five years to ensure they don't develop life-threatening blood clots. The agency also asked Abbott to study how long patients should take anti-clotting drugs to prevent the blockages, said Karen Riley, an FDA spokeswoman.

Boston Scientific is seeking approval for its own new stent, Taxus Liberte. Medtronic's Endeavor, cleared by the FDA in February, and Johnson & Johnson's Cypher are the other products in a market for drug-coated stents that analysts say could top $4 billion a year.

Abbott forecasts that Xience, already approved in Europe, will capture a third of global stent sales in a year. Given the slow pace of regulatory approvals for new medical devices, it should lead the market for at least five years, said John Capek, Abbott's executive vice president for medical devices.

"The market is expecting that this is going to become the leading product in drug-eluting stents," said Michael Weinstein, a J.P. Morgan analyst.