Edwards Lifesciences Corp. reported better-than-expected quarterly earnings on higher sales of its replacement heart valves, but it said the U.S. launch of its latest valve would be delayed.
Irvine-based Edwards had expected to introduce its next-generation tissue valve, called the Magna mitral valve, in the fourth quarter, but said it was responding to questions from U.S. regulators and was no longer confident of that timeline.
Third-quarter net income rose to $29.1 million, or 48 cents a share, from $27.8 million, or 45 cents, a year earlier. In July the company forecast that third-quarter earnings per share would be 41 cents to 43 cents.
Wall Street analysts on average had expected 43 cents a share, according to Reuters Estimates.
The medical device maker said its outlook for full-year sales and earnings was unchanged, but results may move toward the lower end of projected ranges if the Magna mitral valve is not approved in the fourth quarter.
Edwards, which is facing tough competition in heart valve sales from St. Jude Medical Inc., said its third-quarter sales rose 5.7% to $261.4 million. Heart valve therapy sales increased 4.7% to $122.8 million. Critical-care sales grew 13.7% to $96.5 million.
Shares of Edwards Lifesciences gained 15 cents to $49.78.