The US FDA has approved the Sapien M3 System for transcatheter mitral valve replacement, making it the first on the market to use a transseptal approach for the treatment of symptomatic moderate-to-severe mitral regurgitation.[2][7] The system is designed for patients who are not suitable for surgery or transcatheter edge-to-edge repair, including those with mitral anulus calcification.The procedure consists of two steps - a docking system and subsequent valve delivery - and both components are inserted through a sterile puncture in the femoral vein using a 29F guide catheter.[3][7] The system has already received the CE mark in April 2025, making it the first approved transfemoral mitral valve replacement system in the world.[1][3] One-year data from the ENCIRCLE pivotal trial showed that 95.7% of patients achieved elimination of significant mitral regurgitation, with 85% of patients in NYHA functional class I-II.[3][4] Overall mortality at one year was 8.2% and rehospitalization for heart failure was 18.9%, with a 30-day mortality rate of only 0.7%.[4]