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Edwards Says It Expects U.S. Sapien Launch in Late 2011

Irvine-based Edwards Lifesciences Corp. said Monday that it expects to launch its highly touted Sapien replacement heart valve domestically in next year’s fourth quarter.

Sapien, which is inserted via a catheter, and similar products are seen as the biggest advances in heart valves in years because they could open up the market to more patients who aren’t candidates for open heart surgery.

Sapien already is sold in Europe.

Edwards also offered a mixed financial outlook for 2011 during its analyst day presentation in New York.

Edwards could see a profit of $227.1 million to $234.2 million in 2011, below analysts’ consensus average of $252.1 million.

The company said that its profit would be lower because it expects to invest about $40 million to prepare for Sapien’s domestic launch.

“While this will moderate earnings growth in 2011, it allows us to aggressively address this large unmet patient need,” Chief Executive Michael Mussallem told conference attendees.

Edwards said it expected sales of $1.59 billion to $1.67 billion in 2011, in line with analysts’ average forecast of $1.62 billion.

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