The U.S. Food and Drug Administration on Monday approved Edwards Lifesciences Corp’s Sapien 3 artificial heart valve for high-risk patients whose previously implanted heart valves are failing, a procedure designed to avoid repeat open heart surgery.
The product is already approved as an alternative valve replacement procedure for patients at intermediate or high risk of death or severe complications from open heart surgery.
The newly approved valve-in-valve treatment involves placement of a new artificial valve inside a failing valve through a blood vessel or small cut in a patient’s chest, a less invasive procedure than repeat open heart surgery.
The FDA had previously approved the product as an alternative option to replace a natural valve in certain patients at high or intermediate risk of death or complications from open heart surgery.
The agency based its latest decision on data collected from a registry of patient procedures performed in a real-world setting of 314 patients who had undergone aortic valve-in-valve procedures and 311 patients who had undergone mitral valve-in-valve procedures.
The registry data showed that more than 85 percent of patients experienced a clinically meaningful improvement in their heart failure symptoms 30 days after the procedure and death rates were substantially lower than the expected mortality rate for repeat surgery, the FDA said in a statement.
(Reporting by Toni Clarke in Washington; Editing by Jonathan Oatis and Steve Orlofsky)