Peijia Medical-B (09996) Enrolls First Patient in Multicenter Pivotal Clinical Trial of TaurusTrio™ Transcatheter Aortic Valve Replacement System

Zhitong Finance APP reported that Peijia Medical-B (09996) announced the enrollment of the first patient in a multi-center registration clinical trial for its TaurusTrio™ Transcatheter Aortic Valve Replacement (TAVR) System. This system is the Trilogy™ Heart Valve System, developed by JenaValve Technology, Inc. (JenaValve) and licensed exclusively for the treatment of aortic regurgitation. The first implantation was successfully completed on July 26, 2023, by Professor Wu Yongjian and Professor Song Guangyuan at Beijing Anzhen Hospital, Capital Medical University.

It is reported that the system's registration clinical trial is a target value method, prospective, multi-center study aimed at evaluating the safety and effectiveness of the system in treating patients with symptomatic severe aortic regurgitation caused by native valve leaflet disease, who have been assessed by a heart team (including cardiac surgeons) as having high or extremely high surgical aortic valve replacement risks. The results of this clinical trial will be included in the company’s future registration application to the National Medical Products Administration.

In June 2023, the system was officially included in the National Medical Products Administration (NMPA) special approval process for innovative medical devices. As of the date of this announcement, no transfemoral aortic regurgitation TAVR product has been approved by the NMPA in China.