Two-year clinical data of the HighLife® TSMVR technology's feasibility trial involving 30 cases in Europe/Australia were recently announced at TCT2024. Additionally, the HighLife® US Pivotal Trial is set to launch in 2025. HighLife® TSMVR system is anticipated to become the world's first approved transseptal mitral valve replacement system next year.
According to the clinical outcomes, HighLife® TSMVR achieved a technical success rate of 90%. At two years, the all-cause mortality rate among patients was 37%, with five cases of life-threatening bleeding. There were no instances of residual MR≥2+, no LVOT obstruction, no valve-related thrombosis, no residual paravalvular leak closure, and no hemolytic events. All patients maintained reduced regurgitation (MR≤1+) at one-year follow-up, with nearly 80% of patients maintaining NYHA Class I/II at one year. The study results indicate that for patients at high risk for surgical procedures with moderate to severe mitral regurgitation, HighLife® achieved good technical success, met the primary safety and efficacy endpoints, and the two-year followup results confirm the safety, efficacy, and durability of mitral regurgitation elimination with HighLife®.
