Edwards Lifesciences Corp. got some good news from the Food and Drug Administration on Thursday.
Regulators gave the Irvine heart valve maker “conditional” approval to start clinical trials on Cribier-Edwards, a catheter-inserted valve many portend as a growing part of the heart surgery market.
Edwards didn’t disclose the FDA’s conditions for the trial.
The company said that it would have an initial valve feasibility study of 20 patients who are at high risk for conventional heart valve surgery. A second feasibility trial with an additional 40 patients would be conducted upon the first trial’s completion.
“Edwards Lifesciences is eager to begin U.S. clinical trials, and the conditional approval allows us to refine our assumptions regarding the path to approval, which we anticipate occurring in three to four years,” Chief Executive Michael Mussallem said in a release.
Edwards became a heavy player in the less-invasive heart valve market early last year, when it bought Percutaneous Valve Technologies Inc., a New Jersey company, for $125 million.
Last month, Edwards sparred with an analyst who contended that the device maker would need to redesign Cribier-Edwards before getting the go-ahead for a trial.
Meanwhile, after the close of trading Thursday, Edwards reported a profit before taxes of $34.1 million in the fourth quarter, up 26% versus a year earlier. Sales rose 5.8% to $237.1 million in the period.
