Edwards wins FDA approval for mitral heart valve

By Debra Sherman

CHICAGO (Reuters) - Edwards Lifesciences Corp said on Wednesday that it won U.S. regulatory approval for a device to replace diseased mitral valves, one of the most common forms of heart valve abnormalities.

Approval from the U.S. Food and Drug Administration, eagerly awaited by investors after numerous delays, boosted Edwards' stock on hopes that it will help the heart valve maker reverse recent market share losses.

Edwards' Perimount Magna mitral valve will be launched in the United States immediately, making Edwards the only company to have a bovine pericardial mitral valve replacement on the U.S. market.

Mechanical valves last longer than tissue valves, but patients with mechanical replacement valves must take a blood thinner, like Coumadin. Tissue valves are more convenient and those derived from cows are perceived by some physicians to last longer than those from pigs.

Medtronic Inc and St. Jude Medical Inc compete in the mitral valve market with a mix of mechanical valves and valves made from pig tissue.

"Edwards has lost market share to St. Jude and this (product launch) could help turn it around, or at least mitigate those losses," said Tim Nelson, an analyst with FAF Advisors, an asset management firm.

"It will also improve pricing and profit margins and re-energize its sales force."

Wachovia analyst Larry Biegelsen said the smaller profile of the Perimount Magna mitral valve should address the perception that St. Jude's valve is easier to implant.

In a research note, Biegelsen forecast 2008 surgical heart valve sales of $566 million, near the low end of the company's surgical valve guidance of $555 million to $580 million. He said U.S. approval of the Magna mitral valve increases his confidence in those estimates.

Nelson estimated U.S. Magna mitral valve sales of between $30 million and $40 million in 2009.

The Irvine, California-based company, which posted total sales of $1.1 billion in 2007, declined to forecast U.S. sales of the mitral valve, saying only that it believes it can capture U.S. market share with the new offering.

Edwards also declined to disclose Perimount Magna mitral valve sales in Europe, where the product has been available since September 2005.

Edwards, citing industry estimates, said there will be 35,000 to 40,000 surgical mitral valve replacements in the United States this year.

During its second-quarter earnings call, the company raised its 2008 sales outlook for heart valve therapy by $15 million to between $605 million and $625 million.

Shares of Edwards rose as high as $59.91 before trading up 18 cents at $58.42 on the New York Stock Exchange early Wednesday afternoon. The stock hit a record at $66.54 on July 18, 2008.

(Reporting by Debra Sherman; editing by Dave Zimmerman, Richard Chang)