Approval of the first U.S. transcatheter aortic heart valve came slightly later than Edwards Lifesciences anticipated, but Sapien will reach the market just in time for a highly anticipated debut at the Transcatheter Cardiovascular Therapeutics annual meeting in San Francisco this week.
Edwards Lifesciences gained FDA approval Nov. 2 for its Sapien transcatheter valve for severe aortic stenosis patients deemed too sick or frail for open heart surgery, and immediately launched the...