A new heart valve repair device from Edwards Lifesciences Corp. was as effective as the market-leading device from Abbott Laboratories in a clinical study of heart-disease patients, a finding likely to intensify competition in a growing device market.
Edwards said Thursday that its new product, known as Pascal Precision, had been approved by the U.S. Food and Drug Administration for the treatment of a disease called degenerative mitral regurgitation. It will be the first significant competition for Abbott’s MitraClip, which has been on the U.S. market since 2013.