Core Insights - The early feasibility study results for the AltaValve™ transcatheter mitral valve replacement (TMVR) device developed by 4C Medical Technologies, Inc. have been published, showing promising outcomes for high-risk patients with symptomatic severe mitral regurgitation (MR) [1] Group 1: Study Results - The study included 30 high-risk patients across Europe, the United States, and Japan, with 13 patients undergoing the transapical approach and 17 patients undergoing the transseptal approach [1] - The procedural success rate 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-procedure, indicating significant improvement in cardiac hemodynamics [1] - 96% of patients improved to NYHA functional class I-II after one year, reflecting a substantial enhancement in quality of life [1] Group 2: Safety and Mortality - 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] - There were no adverse events such as stroke, new-onset atrial fibrillation, or re-intervention on the mitral valve reported in the entire cohort [1] Group 3: Regulatory Approval - AltaValve™ received two breakthrough device designations from the FDA in 2024 and is currently conducting pivotal clinical studies in Europe and the United States under an FDA-approved Investigational Device Exemption (IDE) [2]
心通医疗-B(02160.HK)：AltaValve™早期可行性研究一年随访结果正式公布