Peijia Medical Ltd (HKG: 9996) has announced the enrollment of the first patient in a multi-center regulatory clinical study for its transcatheter aortic valve replacement (TAVR) system, Taurus Trio. This marks a significant milestone in the development and regulatory approval process for the company’s innovative cardiac device.
Study Design and Patient Population
The study, utilizing the target value method, is a prospective, multi-center trial designed to evaluate the safety and efficacy of the Taurus Trio system in symptomatic patients with severe aortic valve regurgitation due to primary valve disease. These patients, deemed by a heart team that includes cardiac surgeons as being at high-risk or extremely high-risk for surgical aortic valve replacement, are the focus of this clinical investigation.
Product Origin and Licensing Agreement
The Taurus Trio product, originally developed by US-based firm JenaValve Technology Inc., is used to treat aortic valve regurgitation in conjunction with the trilogy heart valve system. Peijia Medical secured a licensing deal with JenaValve in January 2022, thereby acquiring the rights to develop, manufacture, and commercialize the product in Greater China.-Fineline Info & Tech
