微创心通-B：AltaValveTM早期可行性研究一年随访结果正式公布

Core Viewpoint - The announcement highlights the successful one-year follow-up results of the early feasibility study for the AltaValveTM transcatheter mitral valve replacement (TMVR) device developed by 4C Medical Technologies, Inc., indicating significant improvements in patient outcomes and safety [1] Group 1: Study Overview - The study involved 30 high-risk patients with symptomatic severe mitral regurgitation (MR) across multiple centers in Europe, the USA, and Japan [1] - Patients were divided into two groups: 13 underwent the transapical approach, while 17 used the transseptal approach [1] Group 2: Clinical Outcomes - The technical success rate of the procedure was reported at 97%, with complete elimination of MR in all patients [1] - The mean transvalvular pressure gradient decreased from 2.5 mmHg at baseline to 2.1 mmHg post-operation, indicating significant hemodynamic improvement [1] Group 3: Safety Profile - The one-year all-cause mortality rate was 17% for the transapical group and only 7% for the transseptal group, with no cases of cardiac-related mortality [1] - No adverse events such as stroke, new-onset atrial fibrillation, or mitral valve re-intervention were reported in the entire cohort [1] Group 4: Quality of Life Improvement - 96% of patients improved to NYHA functional class I-II at one year, reflecting a substantial enhancement in quality of life [1] Group 5: Regulatory Status - AltaValveTM received two breakthrough device designations from the FDA in 2024 and is currently conducting pivotal clinical studies in Europe and the USA under an FDA-approved Investigational Device Exemption (IDE) [1]