Edwards Lifesciences faces scrutiny over unapproved device

12/4/2008 | Reuters

Sen. Charles Grassley, R-Iowa, is looking into allegations that Edwards Lifesciences Corp.'s Myxo Ring, an annuloplasty product used in heart valve repair, is being used in patients at a Chicago hospital without FDA approval. The company said it has pulled the device from its Web site and halted its distribution.

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