Edwards secures FDA approval for Sapien 3 with Alterra Prestent for Transcatheter Pulmonic Valve Replacement
Edwards Lifesciences declared to receive approval from the U.S. Food and Drug Administration (FDA) to use the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent (SAPIEN 3 with Alterra) for severe pulmonary regurgitation patients.
The Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) system combines the proven SAPIEN 3 transcatheter heart valve and the Alterra adaptive prestent to extend transcatheter therapy options for congenital heart valves disease patients. The Alterra prestent makes up for variations in size and morphology of ...
