Edwards Lifesciences Corp. of Irvine said Tuesday the Food and Drug Administration cleared it to start a clinical study on a less-invasive heart valve.
Edwards’ study, called Partner, is set to evaluate its Sapien replacement valve in some 600 patients who are considered too high-risk for conventional open-heart valve surgery.
Sapien is inserted via a catheter.
The device maker stopped an earlier study in 2005 after some patients suffered serious complications, including death.
Wall Street is closely watching Edwards’ efforts to get into the less-invasive valve business in hopes that it will eventually become the standard of care for patients who need their heart valves replaced.
Patients will be initially enrolled at New York-Presbyterian/Columbia University Medical Center and the Cleveland Clinic Foundation. Edwards has to submit follow-up data from a feasibility study before the trial can be expanded to up to 15 hospitals around the country.
Edwards said the primary goal is to ensure patient survival for at least a year; secondary goals are valve performance and quality-of-life measures.
