The U.S. Food and Drug Administration approved an expanded indication for Edwards Lifesciences Corp.'s Sapien 3 transcatheter heart valve for symptomatic heart disease patients due to the failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater.
Previously, the regulator approved the valve for transcatheter aortic valve replacement as an alternative option to surgical aortic valve replacement for patients with native aortic stenosis whose risk for death or severe complications from surgery is high or greater. In 2016, the FDA expanded the approved the transcatheter aortic valve replacement indication for the valve to include patients who are at intermediate surgical risk for death or complications.
The FDA evaluated data from the Transcatheter Valve Therapy Registry. The data showed that more than 85% of patients who underwent aortic or mitral valve-in-valve procedures experienced clinically meaningful improvement in their heart failure symptoms 30 days after the procedure, as shown by their New York Heart Association Classifications, a classification system by which heart failure symptoms are rated.
In both aortic and mitral valve-in-valve patients, the observed mortality rates were substantially lower than the expected mortality rate for repeat surgery.
As part of the approval, the manufacturer will participate as a stakeholder of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry to ensure FDA surveillance for the device over the next five years.