Peijia Medical has announced that the first Chinese patient has been enrolled in the clinical trial of its TaurusTrio transcatheter aortic valve implantation (TAVI) device
TaurusTrio is the licensed version of JenaValve’s Trilogy heart valve system, which has been developed for the treatment of aortic regurgitation (AR), after Peijia Medical obtained an exclusive licence for the development, manufacture and commercialisation of the device in the Greater China region in January 2022.
The first implant was successfully completed by Yongjian Wu and Guangyuan Song at Beijing An Zhen Hospital, Capital Medical University on 26 July.
“We are pleased to have safely implanted the first patient in China with the TaurusTrio TAVI system,” said Yi Zhang, chief executive officer of Peijia Medical. “The trial reinforces our goals of improving care in the field of cardiology and expanding TAVI systems within China. We are looking forward to our continued partnership with American company, JenaValve and presenting further data from the clinical trial at a future date.”
The clinical trial of the TaurusTrio TAVI system is designed to assess the safety and efficacy of the system for treating patients with native symptomatic, severe AR, who are judged by a heart team to be at high or greater risk for surgical aortic valve replacement (SAVR). The result of the clinical trial would be included in the company’s future submission of registration application to the National Medical Products Administration (NMPA).
Currently, there are no transfemoral TAVI systems approved by the NMPA in China for the AR indication. In June 2023, TaurusTrio TAVI system was accepted by the Special Review and Approval Procedure for innovative medical devices of the NMPA.