On January 26, 2026, HighLife SAS, an innovative French medical company, announced a significant milestone: its Transseptal Mitral Valve Replacement system (HighLife TSMVR) successfully obtained European CE Mark certification, officially granting market access in Europe. This landmark achievement not only provided a new minimally invasive treatment option for patients with mitral regurgitation (MR) in Europe but also injected new momentum into the global field of interventional structural heart disease treatment, backed by its differentiated technological design and excellent clinical data.
Peijia Medical signed a technology transfer license agreement with HighLife in December 2020, securing exclusive rights for the HighLife TSMVR system's patents, manufacturing, development, and sales in Greater China. In China, the first Asian implantation of HighLife TSMVR successfully completed by Professor Chen Mao's team at West China Hospital, Sichuan University, in December 2021. Simultaneously, Peijia and HighLife were accepted into the NMPA Innovative Device Special Review Process in September 2022, potentially accelerating its registration and approval in China. The registration clinical trial in China progressed rapidly, with the longest follow-up data reaching two years.
Leveraging the mar ket access advantages from EU certification, coupled with the steady progress of pivotal clinical trial in the US and registration clinical trial in China, HighLife TSMVR accelerated the of a global commercialization network, embarking on a new journey of global clinical application and value transformation for innovative interventional mitral valve replacement therapy.
