Abbott stent should be sold in U.S., FDA panel says

Abbott Laboratories' experimental heart stent should be cleared for sale because it works as well as devices already on the market to prop open clogged arteries, a U.S. advisory panel said.

Outside experts for the Food and Drug Administration voted 9-1 today to recommend that the stent, called Xience, be approved. The panel also said the Abbott Park, Illinois, company should do long-term studies on whether the drug-coated device causes potentially deadly blood clots.

The FDA is considering whether to clear Xience to compete with Boston Scientific Corp.'s Taxus and Johnson & Johnson's Cypher, the two drug-coated stents already on the U.S. market. Sales of the devices plunged 40 percent last year to $2 billion in the U.S. over concerns about clots. Xience is racing Medtronic Inc.'s Endeavor to become the first in a new generation of stents to win U.S. approval.

"I certainly think the early safety data are encouraging, but we need more information," said panel chair Clyde Yancy, medical director of Baylor Heart and Vascular Institute in Dallas, at the meeting today. "I trust the post-marketing study will assuage our concerns."

Abbott gained 74 cents, or 1.3 percent, to $57.74 in trading after the close of the New York Stock Exchange.

"There was a lot of concern that the panel would not recommend approval" due to insufficient safety data, said Joanne Wuensch, an analyst with BMO Capital Markets in New York, in an e-mail. ' 'This is a nice positive."

The FDA usually follows the advice of its advisory panels, although it isn't required to do so. The panel met today in Gaithersburg, Maryland.