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UPDATE 3-Edwards Q1 profit beats, but 2012 outlook cut
* Q1 profit of 53 cents without items vs 48 cents view
* Strong rollout of new heart valve boosts quarterly profit
* Cuts full-year profit outlook by 12 cents on FDA panel delay
* Shares rise 3.6 percent in after-hours trading
By Susan Kelly
April 24 (Reuters) - Edwards Lifesciences Corp posted a better-than-expected quarterly profit on a strong launch for a new heart valve, but cut its full-year outlook, citing a delay in U.S. approval of the product for an expanded group of patients.
Shares of the medical device maker rose 3.6 percent after hours on the strong first-quarter results.
Edwards is rolling out its Sapien transcatheter heart valve after winning U.S. approval for the product in November for patients deemed too sick to undergo traditional open-heart surgery for valve replacement. The new valve is implanted via a catheter threaded to the heart through a leg artery or small incision between the ribs.
A U.S. Food and Drug Administration panel is scheduled on June 13 to consider whether the valve can be implanted in an additional high-risk patient group. Edwards had been hoping for an earlier panel date, which would have given sales a further boost.
The strong U.S. rollout for the new valve drove a 5-cent beat in the company's first-quarter earnings.
"The big focus is that U.S. sales are doing much better than anyone was expecting," said Jefferies analyst Raj Denhoy.
Irvine, California-based Edwards reported first-quarter net earnings on Tuesday of $65.1 million, or 55 cents per share, compared with net income of $63.9 million, or 53 cents per share, a year ago.
Excluding special items, first-quarter earnings were 53 cents per share. Analysts on average expected 48 cents per share, according to Thomson Reuters I/B/E/S.
Edwards said net sales rose 13.5 percent to $459.2 million in the quarter. Sales of transcatheter heart valves rose 67.2 percent to $121.5 million. U.S. sales of the Sapien transcatheter valve were $41 million.
The medical device maker said so far it has trained 60 U.S. hospitals to implant the Sapien valve.
Analysts had been concerned that lack of a national Medicare reimbursement policy for the new valve would hamper sales. Regional Medicare offices are now considering reimbursement for the product on a case-by-case basis.
"Reimbursement uncertainty has caused some centers to postpone their training and others to delay procedures. However, physician and hospital interest in our Sapien program remains very high," Edwards Chief Executive Michael Mussallem told analysts on a conference call.
The company expects Medicare, the U.S. insurance program for the elderly, to issue a final coverage decision for the Sapien valve in early May.
Mussallem said physicians are working to address concerns raised by study data presented at a medical meeting last month that showed a possible link between leakage around the implanted valve and higher mortality rates.
Physicians are focused on adjustments that include improving the valve fit by altering the sizing of the device, he said.
Edwards cut its full-year profit forecast by 12 cents to a new range of $2.58 to $2.68 per share, citing the one-quarter delay in the date set for the FDA panel.
Analysts had been anticipating the company would lower its full-year forecast due to the delayed panel date.
It lowered its 2012 forecast for Sapien valve sales by $30 million, to a range of $530 million to $600 million. It now expects overall company sales this year at the low end of its prior forecast of $1.95 billion to $2.05 billion.
Edwards shares rose 3.6 percent to $76 in after-hours trading, from a Tuesday close of $73.33 on the New York Stock Exchange.
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