NEW YORK (AP) -- Edwards Lifesciences Corp. said Sunday that patients who were implanted with its new Sapien XT heart valve did about as well as patients who received an older version of the valve.
Edwards said the rates of death and stroke among the two groups of patients were similar. However the rate of "vascular events" was lower in patients who had the Sapien XT valve. The results came from an ongoing clinical trial, and Edwards plans to submit them to the Food and Drug Administration as it seeks marketing approval for Sapien XT. The device is approved in Europe and other markets, but hasn't been cleared in the U.S.
Jefferies & Co. analyst Raj Denhoy said the results were "very encouraging" for the new, smaller valve.
Sapien is designed to replace diseased heart valves. It is designed to be guided to the heart through an artery in the leg. The diseased valves are normally are removed through open heart surgery, which is a more complicated procedure. The FDA approved Sapien in November 2011 for patients who couldn't have open heart surgery. In October, the agency expanded that approval to cover patients for whom surgery was considered high-risk.
Sapien XT is a smaller
Edwards reported data from a separate clinical trial Monday, saying the original Sapien valve worked as well as open heart surgery after three years. The company said the death rate among Sapien patients and open heart surgery patients was statistically equivalent. Symptom improvement and heart valve performance were also similar, as was the rate of stroke.
Shares of Edwards lost $2.13, or 2.4 percent, to $88.17 in afternoon trading. They have gained about 28 percent in the past year.
- Tests & Procedures