Edwards Lifesciences hits all-time high after Sapien valve succeeds in clinical trial

Edwards Lifesciences surges on Sapien trial data

NEW YORK — Shares of Edwards Lifesciences Corp. rocketed to an all-time high Thursday after the New England Journal of Medicine published positive clinical trial results for Edwards’ Sapien heart valve.

THE SPARK: Late Wednesday, the medical journal reported results from PARTNER, a study of 358 patients that compared the Sapien valve to standard therapies in patients who had severe aortic stenosis, or a narrowing of the main artery that carries blood away from the heart. The authors conclude that Sapien “should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery.”

The study showed that patients who received the Sapien valve were less likely to die, be hospitalized, or have heart problems in the first year after implantation; however, they were more likely to have a major stroke.

Sapien is designed to replace diseased heart valves. It is intended to be guided to the heart through an artery in the leg. Typically, the diseased valves are removed through open heart surgery, which is a more complicated procedure.

After one year, 30.7 percent of the Sapien patients had died, compared to 50.7 percent of patients in the standard treatment group. The rate of death from heart problems was also lower in the Sapien group.

Separately, Edwards said Thursday that it received approval to start a clinical trial of Sapien XT, a newer version of the valve. It said the Food and Drug Administration granted conditional approval to one of the two patient populations in the proposed study.

THE BIG PICTURE: Sapien has not been approved in the U.S., but trial results showing it is more effective than standard therapy could improve its chances at winning clearance from the Food and Drug Association.

SHARE ACTION: Shares of the Irvine, Calif., company jumped $7.36, or 12 percent, to $67.06 in afternoon trading. Earlier they reached a high of $69.29. The stock has traded between $33.53 and $61.56 over the last 12 months.

(This version CORRECTS Sapien XT to Sapien)