Minimally Invasive Heart Tong-B (02160): One-year follow-up results of the AltaValveTM Early Feasibility Study Officially Announced

Zhitong Finance App News, Minimally Invasive Xintong-B (02160) issued an announcement. Recently, the results of a one-year follow-up study on the early feasibility study of AltavalveTM transcatheter mitral valve replacement (TMVR) medical device (AltavalveTM) independently developed by 4C Medical Technologies, Inc. (4C Medical), a group affiliate, were officially announced.

The study covered multiple centers in Europe, the United States, and Japan, and included 30 patients, all of whom had a high risk of surgery and symptomatic severe mitral valve reflux (MR). Among them, 13 patients used the transcardiac tip approach and 17 used a transatrial septum route. One-year follow-up results showed that the success rate of surgical techniques was as high as 97%. MR was completely eliminated in all patients. The mitral valve cross-valve pressure difference dropped from an average of 2.5 mmHg at baseline to 2.1 mmHg after surgery, and cardiac hemodynamics improved markedly. In terms of safety, the one-year all-cause mortality rate was 17% in the transventricular septum group, and only 7% in the transatrial septum group, and the central origin mortality rate was 0. There were no adverse events such as stroke, new atrial fibrillation, or mitral valve reintervention in the entire cohort. 96% of patients were upgraded to grade I-II cardiac function by the New York Heart Association (NYHA) in one year, and their quality of life improved significantly.

AltaValveTM has received two breakthrough device titles from the US Food and Drug Administration (FDA) in 2024, and has carried out key clinical studies in Europe and the US under the FDA-approved Medical Device Exemption (IDE).