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Edwards: Heart Valve Effective for High-Risk Patients

Edwards Lifesciences Corp. of Irvine said Monday that nearly two-thirds of high-risk patients who received its less-invasive heart valve remained alive two years after treatment.

Edwards, a maker of heart valves and other devices, said that 64% of 339 patients who received its Sapien heart valve in a Canadian study were alive two years after they received the valve.

The study looked at patients who were considered either inoperable or at a high risk for traditional open-heart surgery to treat severe aortic stenosis, or a narrowing of a valve that restricts blood flow.

Half of the patients got Sapien via a catheter inserted through the femoral artery in the thigh, while the other half got it through a small incision in the ribs.

The minimally invasive devices are seen as the biggest development for heart valve makers in years.

Edwards is conducting a major U.S. trial for Sapien with an eye towards Food and Drug Administration approval in late 2011. The company already sells Sapien in Europe and has projected $100 million of sales for it in 2009.

The device maker presented the study findings at the Transcatheter Cardiovascular Therapeutics scientific meeting in San Francisco.

Edwards also presented 12-month follow-up data from a European trial for Sapien that showed improved physical and mental well-being in patients who got the valve and gains in physical activity as measured by functional tests.

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