Irvine-based Edwards Lifesciences Corp. said Wednesday that its next-generation transcatheter heart valve has been implanted in three people as part of ongoing testing of the device.
John Webb, a heart surgeon and director of the catheter lab and cardiac intervention at St. Paul’s Hospital in Vancouver, British Columbia, implanted the valves into the patients.
Edwards said it expects to start a clinical trial of the valve in Europe before the end of the year.
The less-invasive valve, called Sapien, is being evaluated with two separate delivery systems for Food and Drug Administration approval.
The device maker stopped an earlier study in 2005 after some patients suffered serious complications, including death.
The latest testing involves a new version of the valve and catheter used to implant it.
Heart valves that don’t require major surgery for implantation are a key project for Edwards, the longtime market leader in heart valves.
