Edwards Heart Valve Offers Surgery Alternative to More Patients

  • Sapien XT proves as safe and effective as open-heart surgery
  • Study tracked intermediate-risk patients who now get surgery

Edwards Lifesciences Corp.’s Sapien XT aortic valve, which doctors slip into the heart via a catheter, was just as safe and effective as standard open-heart surgery in a study of lower-risk patients who don’t currently qualify for the device.

While more than 150,000 patients have received transcatheter aortic valves in a procedure called TAVR, use in the U.S. has been restricted to those either too sick to have the chest cut open or at extremely high risk of dying if they do have the standard surgery. The results from the study of more than 2,000 patients in the U.S. and Canada point to an expansion of the market to treat narrowed aortic valves for Edwards and its main rival for sales of the devices, Medtronic Plc.

The company expects expanded approval for Sapien XT’s use in patients at intermediate risk by the end of the year, Larry Wood, vice president for transcatheter heart valves, said in December at Edwards’s investor day. Use in healthier patients is expected to boost the market for the devices to $5 billion by 2021, Chief Executive Officer Michael Mussallem said at the time. 

About 19.3 percent of patients getting Sapien XT died or suffered a disabling stroke -- the study’s main measures -- within two years of treatment, compared to 21.1 percent among those undergoing open-heart surgery. When conditions allowed doctors to insert Sapien XT from the groin through the femoral artery, rather than a small hole in the chest, the rate of severe complications fell even lower.

The results were presented Saturday at the American College of Cardiology’s annual meeting in Chicago and simultaneously published in the New England Journal of Medicine. A second study of Sapien 3, the latest TAVR valve from Irvine, California-based Edwards, will be presented at the meeting Sunday, along with sessions that include the latest data on Medtronic’s competing CoreValve device. 

The results “seem to confirm that TAVR is the treatment of choice in most patients with aortic stenosis who are at high risk for early death and major complications from conventional surgery,” said Neil Moat, a cardiac surgeon at the Transcatheter Valve Programme of Royal Brompton Hospital in London, in an editorial that accompanied the study. “The findings have to be interpreted with the understanding that the technology, in both groups, has advanced since the design of the trial.”

Edwards shares rose 1.9 percent Friday to close at $89.92 in New York. They have gained 14 percent since the year began.

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