From June 5 to 7, 2024, the New York Valves (NYV) conference was held, where Prof. Nicolo Piazza of McGill University Health Centre updated attendees on the latest clinical progress of Peijia's HighLife® transseptal mitral valve replacement technology. The iterations of the HighLife® TSMVR system, specifically the Clarity and Large Annulus Valve, address current unmet clinical needs and improve patient screening success rates. More than 30 centers and over 110 patients worldwide have benefited from HighLife® TSMVR system. 

Moreover, Prof. Nicolo Piazza also announced that the U.S. Food and Drug Administration (FDA) granted an Investigational Device Exemption (IDE) to initiate a US Pivotal Study with HighLife® TSMVR system. The Pivotal Study is a single-arm, multicenter, prospective study assessing the safety and effectiveness of the HighLife® TSMVR solution in patients with moderate to severe functional mitral regurgitation (FMR) who are unsuitable for surgery or transcatheter repair treatment. The pivotal study is expected to enroll patients at clinical sites in the United States, Europe and APAC. The initiation of this pivotal study will signal the accelerated globalization of HighLife® TSMVR system, laying a solid foundation for commercial approval in more regions around the world.