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Edwards Is Approved to Restart Heart Valve Trial

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From Reuters

Edwards Lifesciences Corp. said it received U.S. regulatory approval to restart a clinical trial that would allow doctors to implant a heart valve without open-heart surgery.

Edwards said the trial used a new, simpler approach and involved a larger heart valve. The 20-patient trial is designed to test the feasibility of delivering a heart valve without surgery.

In June, Irvine-based Edwards voluntarily halted its earlier trial because the approach to the heart was too complicated and some patients died.

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