Minimally Invasive Heart Communication-B (02160): The one-year follow-up results of the AltaValveTM early feasibility study have been officially announced.

Minimally Invasive Heart Communication-B (02160) announced that the early feasibility study results of AltaValveTM for transcatheter mitral valve replacement (TMVR) developed independently by its joint venture company 4C Medical Technologies, Inc. (4C Medical) have been officially released. This study covered multiple centers in Europe, the United States, and Japan, with 30 patients enrolled, all of whom were high-risk surgical patients with symptomatic severe mitral regurgitation (MR). Thirteen patients underwent transapical access, while 17 underwent transseptal access. The one-year follow-up results showed a high surgical success rate of 97%, complete elimination of MR in all patients, a decrease in mean mitral valve gradient from baseline of 2.5mmHg to 2.1mmHg postoperatively, and significant improvement in cardiac hemodynamics. In terms of safety, the one-year all-cause mortality rate was 17% in the transapical group and only 7% in the transseptal group, with a 0% rate of cardiac-related death. Throughout the cohort, no adverse events such as stroke, new-onset atrial fibrillation, or mitral valve reintervention occurred. 96% of patients improved to NYHA functional class I-II at one year, with a significant improvement in quality of life. AltaValveTM has received two breakthrough device designations from the Food and Drug Administration (FDA) in 2024 and has been conducting key clinical studies in Europe and the United States under investigational device exemption (IDE) approved by the FDA.