January 29, 2008 - Edwards Lifesciences Corp. received conditional approval from the FDA for the addition of the Ascendra transapical delivery system to the U.S. pivotal clinical trial of the Edwards SAPIEN transcatheter aortic heart valve technology.
The FDA also granted permission to Edwards to increase its trial sample size from 600 patients to 1,040 patients. These approvals enable Edwards to address a larger population of patients who may have few or no options for treatment of their heart valve disease.