Edwards Heart Valve Extended Life, Raised Stroke Risk in Study

SFGate

Edwards Lifesciences Corp.'s cardiac valve implanted without open-heart surgery prevented 45 percent more deaths after a year than standard treatment, a study found. The valve also doubled the risk for strokes.

The device, called Sapien, kept 69 percent of frail, elderly patients alive, compared with 49 percent who received traditional therapies, according to the company-funded study published online today in the New England Journal of Medicine.

Edwards, based in Irvine, California, will use today's results and additional research on healthier people to seek U.S. approval of its $30,000 valve next year. If Sapien is safer and works as well as alternatives, Edwards can double sales to $2.8 billion in five years, analysts surveyed by Bloomberg projected.

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