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Survival rates climb for two heart valves

October 14, 2008|From Bloomberg News

Edwards Lifesciences Corp.'s minimally invasive heart valve kept 94% of patients alive a month after surgery, the best results yet for a technology that may grow into a $1.3-billion market for medical device makers.

The death rate was half that in past studies of Sapien, a $30,000 valve that can be implanted without open-heart surgery. In another trial, closely held CoreValve Inc. reported a 93% survival rate after 30 days for its device. The studies were released at the Transcatheter Cardiovascular Therapeutics conference in Washington on Monday, before an audience of doctors, medical device makers and industry analysts.

CoreValve's study followed 1,243 patients and found a 7% death rate at 30 days, also an improvement over previous studies.

The devices replace the aortic valve, the three-flapped spigot between the heart's main pumping chamber and the artery that carries blood to the body. They're inserted on a slender catheter threaded through a cut in the groin or chest, avoiding chest-splitting surgeries that require doctors to temporarily stop the heart. That may make them a "game changer" for device makers, said Spencer Nam, an analyst with Summer Street Research Partners in Boston.

"Up until now, without these devices, you couldn't approach high-risk patients" who were too frail for surgery, Nam said. "With the baby boomers aging, there's going to be a big population out there for this procedure."

The companies, both based in Irvine, are the only ones cleared to sell the valves in Europe, though Johnson & Johnson and Medtronic Inc. have expressed interest in the technology. Edwards has said that as many as 50,000 U.S. patients a year, who are too sick or old for traditional heart surgery, may benefit from the device.

Shares of Edwards rose $6.20, or 12.5%, to $55.70.

Edwards expects to win U.S. approval by 2011 if Sapien succeeds in future trials. CoreValve is still negotiating the scope of its U.S. trial with the Food and Drug Administration, Chief Executive Daniel Lemaitre said.

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