Edwards Lifesciences Corp. said Thursday that the Food and Drug Administration has conditionally approved its plans to restart a clinical trial for the company’s less-invasive Cribier-Edwards heart valve that is inserted without open-heart surgery.
The Irvine-based device maker voluntarily suspended the trial in June after it found that the procedure carried too many complications, with some patients dying.
Edwards said the new trial, which will involve 20 patients at three clinical sites, will use a delivery system that involves a simpler route,threading it through a patient’s circulatory system from the leg directly to the aortic valve.
The device maker said that when the feasibility study is done, it would work with the FDA to determine the next steps in getting regulatory approval for the procedure.
Edwards acquired the less invasive Cribier-Edwards valve in 2003, when it spent $125 million for Percutaneous Valve Technologies, a New Jersey-based device maker.
Shares of Edwards have been under pressure since it stopped the trial in summer. Shares were slightly higher Thursday to $40.
