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ENCIRCLE Evaluates Edwards Sapien M3 TMVR System for MR Reduction

October 27, 2025—Results from the ENCIRCLE pivotal clinical trial demonstrated effective reduction of mitral regurgitation (MR) with low rates of complications and mortality using a fully percutaneous transseptal mitral valve replacement (TMVR) procedure in patients with symptomatic, moderate-to-severe MR who are not candidates for conventional surgery or transcatheter edge-to-edge repair procedures.

Edwards Sapien M3 Transseptal TMVR System Approved by FDA

December 23, 2025—Edwards Lifesciences announced FDA approval for the company’s Sapien M3 transcatheter mitral valve replacement (TMVR) system as a transseptal therapy for the treatment of mitral regurgitation (MR).

BiVacor Receives Grant to Support Clinical Trials for Total Artificial Heart

February 20, 2024—BiVacor, a clinical-stage medical device company based in Australia and California, announced an award of US$13 million from the Australian Government’s Medical Research Future Fund (MRFF) grant through the Artificial Heart Frontiers Program (AHFP).