FDA Approves Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy
On December 23, 2025, Edwards Lifesciences announced that its SAPIEN M3 mitral valve replacement system, the first transcatheter therapy using a transseptal approach, received approval from the US Food and Drug Administration (FDA) for the treatment of mitral regurgitation (MR). The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system was approved for treating patients with symptomatic moderate-to-severe or severe MR who were considered unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy, as determined by a multidi...
