Abbott stent clears major FDA step

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 Thursday to urge that the drug-coated stent, called Xience, be approved. The panel also said the Libertyville-Township based company should do long-term studies on whether the 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 concern about clots. Xience is racing Minneapolis-based Medtronic Inc.'s Endeavor to become the first in a new generation of stents to win U.S. approval.

"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 Thursday. "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.

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

"The outcome of today's advisory committee meeting is very encouraging," said John Capek, Abbott's executive vice president for medical products, in a statement.

After two years, Xience kept arteries open in a trial as well as Taxus, and was about half as likely to cause heart attacks, repeat procedures or death, Abbott representatives said. Several FDA panel members said the company needed longer-term data from more patients to demonstrate safety.

"I voted against the approval because I felt the safety data was inadequate and this is a bad precedent to set," said panel member John Somberg, a professor of pharmacology at Rush University in Chicago.

An FDA review panel last month recommended clearance of the Medtronic stent after studies found the device worked as well as the older Taxus. The advisory panel considering Endeavor also recommended long-term studies after that stent is on the market.