Edwards’ Sapien Device as Effective as Open Heart Surgery
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Edwards Lifesciences Corp.’s Sapien device, inserted into the heart via a catheter to fix a diseased aortic valve, is as safe and effective as open heart surgery for as long as three years, researchers said.
The study presented at the American College of Cardiology meeting in San Francisco provides reassuring data about the device approved in the U.S. in October as the first alternative to traditional surgery. The trial, dubbed Partner, found 44.8 percent of surgery patients died within three years, compared with 44.2 percent of Sapien patients.