Peijia Medical’s TaurusTrio TAVR System Implanted in First Patient in China in Clinical Trial

August 1, 2023—Peijia Medical, which is headquartered in Suzhou, China, announced that the first patient was enrolled in the registration clinical trial for the company’s TaurusTrio transcatheter aortic valve replacement (TAVR) system. TaurusTrio is the licensed-in Trilogy heart valve system for aortic regurgitation (AR) from JenaValve Technology, Inc.

According to the company, the multicenter clinical trial is designed to assess the safety and efficacy of the TaurusTrio TAVR system for treating patients with native symptomatic, severe AR, who are judged by a heart team (including a cardiac surgeon), to be at high or greater risk for surgical aortic valve replacement.

The first implantation was performed by Professors Yongjian Wu, MD, and Guangyuan Song, MD, at Beijing An Zhen Hospital, Capital Medical University in Beijing, China on July 26, 2023.

As announced in January 2022, Peijia Medical obtained an exclusive license from JenaValve for developing, manufacturing, and commercializing the Trilogy system in the Greater China region. The first two commercial implantations with the Trilogy heart valve system were successfully completed in Hong Kong on May 12, 2023.

The clinical trial result will be included in the company’s future submission of the registration application to the National Medical Products Administration (NMPA). The TaurusTrio TAVR system was accepted by the Special Review and Approval Procedure for innovative medical devices of the NMPA in June 2023. Currently, no transfemoral TAVR system for AR has been approved by the NMPA in China, noted the company.