Core Insights - The early feasibility study results for the AltaValveTM transcatheter mitral valve replacement (TMVR) device developed by 4C Medical Technologies, Inc. have been published, showing promising outcomes in high-risk patients with symptomatic severe mitral regurgitation (MR) [1][2] Group 1: Study Results - The study included 30 patients across Europe, the United States, and Japan, all of whom were at high surgical risk and had symptomatic severe MR [1] - 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-procedure, indicating significant improvement in cardiac hemodynamics [1] Group 2: Safety and Outcomes - 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] - 96% of patients improved to NYHA functional class I-II at one year, reflecting a substantial enhancement in quality of life [1] Group 3: Regulatory Status - AltaValveTM has received two breakthrough device designations from the FDA in 2024 and is currently undergoing pivotal clinical studies in Europe and the United States under an FDA-approved Investigational Device Exemption (IDE) [2]
微创心通-B(02160)：AltaValveTM早期可行性研究一年随访结果正式公布