On March 18, JenaValve Technology, Inc., developer and manufacturer of the Trilogy Transcatheter Heart Valve (THV) System, announced that the FDA has granted premarket approval of the Trilogy THV System for the treatment of patients with symptomatic, severe AR who are at high or greater risk for surgical aortic valve replacement.
This approval makes the Trilogy THV System the first and only transcatheter device in the United States with a dedicated indication for eligible patients. In January 2022, Peijia Medical entered into an exclusive license agreement with JenaValve, introducing this global innovation to China. As the homologous technology to Trilogy in China, TaurusTrio received NMPA approval earlier, in December 2025.
