Mass. firm says stents cleared by FDA

NEW YORK - Boston Scientific Corp., the leading seller of heart stents, says US regulators have agreed to lift the remaining restrictions preventing the company from issuing new versions of the artery-clearing devices.

The Food and Drug Administration told the company Tuesday it planned to remove the penalties imposed in January 2006 when the device maker was cited for manufacturing violations, said James Tobin, Boston Scientific's chief executive, in a conference call with analysts yesterday.

The move should lead to approvals for two new stents to open blockages in the carotid artery and kidney, and a balloon catheter for unclogging blood vessels, Tobin said. It also removes a potential hurdle for future products the Natick, Mass., company aims to introduce in the $4 billion market for heart stents and other devices.

"We were informed by the FDA yesterday that we are in substantial compliance with its quality system regulations, and that the agency has agreed to remove the restrictions," Tobin said on the call, which followed Tuesday's earnings report.

Boston Scientific fell 43 cents, or 5 percent, to $8.19 in New York Stock Exchange composite trading.

The company also lowered its forecast for 2008 earnings to 78 to 83 cents a share, from 83 to 84 cents forecast in July. Chief financial officer Sam Leno cited a delay in FDA approval for the firm's newest heart stent, Taxus Liberte, which had been blocked until the agency lifted some of the restrictions on Oct. 10.

FDA spokesmen said they had no immediate comment.