Irvine medical device maker Edwards Lifesciences Corp. said Tuesday that a clinical trial for its LifeStent product showed “statistically superior results.”
LifeStent is used to treat disease in arteries in the upper leg and knee.
The company said the trial compared the use of LifeStent to traditional balloon angioplasty when treating peripheral arterial disease.
Edwards now is talking with the Food and Drug Administration for pre-market approval of LifeStent to be used in the superficial femoral artery.
Shares of Edwards closed down 3% with a market value of $2.75 billion Tuesday.
Late Monday, the company said the U.S. launch of its Magna mitral replacement heart valve would be delayed.
Edwards had expected to introduce the valve in the current quarter, but said it was responding to questions from the FDA and was no longer confident of that timeline.
