MP CARDIOFLOW-B (02160) announced that the one-year follow-up results for the early feasibility study of the AltaValveTM transcatheter mitral valve replacement (TMVR) medical device, independently developed by its associate company, 4C Medical Technologies, Inc. (4C Medical), have been formally released. The study was conducted across multiple centers in Europe, the United States, and Japan, enrolling 30 patients who were all at high surgical risk and suffering from symptomatic severe mitral regurgitation (MR); of these, 13 patients were treated via a transapical approach, while 17 underwent a transseptal approach. The one-year follow-up results demonstrated a notably high procedural technical success rate of 97%, with MR being completely eliminated in all patients; the mean mitral valve gradient decreased from a baseline of 2.5 mmHg to 2.1 mmHg post-procedure, indicating a significant improvement in cardiac hemodynamics. Regarding safety, the one-year all-cause mortality rate was 17% in the transapical group, compared to just 7% in the transseptal group, with cardiac mortality recorded at 0% in both cohorts. Throughout the entire patient group, no adverse events such as stroke, new-onset atrial fibrillation, or mitral valve re-intervention were reported. A substantial 96% of patients achieved a New York Heart Association (NYHA) functional class of I-II at the one-year mark, reflecting a major enhancement in their quality of life. The AltaValveTM has already received two Breakthrough Device designations from the U.S. Food and Drug Administration (FDA) in 2024 and is currently undergoing pivotal clinical studies in Europe and the United States under an FDA-approved Investigational Device Exemption (IDE).