Edwards Is Approved to Restart Heart Valve Trial
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.