Orange County Business Journal

Edwards Disputes Comments on Sapien

Vita Reed Monday, October 17, 2011

Shares of Edwards Lifesciences Corp. fell today on reports that a Food and Drug Administration decision on its highly touted Edwards Sapien heart valve could be delayed until next year.

The Irvine-based device maker disputed the report. It said it expects FDA approval later this month for Edwards Sapien, which is already on the market in Europe.

Edwards’ stock closed down some 5% in Monday trading, to a market value of about $7.9 billion after a report by analyst Larry Biegelsen of Wells Fargo Securities. Biegelsen said that Jeffrey Borer, a cardiologist on a Food and Drug Administration review panel, publicly stated at a Chicago medical meeting that Edwards Sapien wouldn’t be approved until April 2012.

Biegelsen’s report shook some investors despite his notation that “we believe Dr. Borer was just speculating and we remain confident that Sapien will be approved shortly.”

Borer was one of nine panel members who unanimously recommended that the FDA approve Sapien in July. The agency generally follows the recommendations of its outside advisory panels.