First TAVR System Approved for Severe Aortic Regurgitation

FDA Approves Trilogy TAVR System for Severe Aortic Regurgitation: Study

The FDA has approved the Trilogy Transcatheter Heart Valve System for treating patients with symptomatic severe aortic regurgitation. It is the first and only TAVR device specifically indicated for...

First TAVR System Approved for Severe Aortic Regurgitation

(MedPage Today) -- The FDA approved the Trilogy Transcatheter Heart Valve System for the treatment of symptomatic severe aortic regurgitation, device maker JenaValve Technology announced. This approval makes Trilogy the only transcatheter aortic...

JenaValve Announces FDA Approval of the Trilogy™ Transcatheter Heart Valve System — the First ...

IRVINE, Calif., March 18, 2026 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of the Trilogy…

Trilogy valve gains US FDA premarket approval

JenaValve’s Trilogy valve JenaValve Technology has announced that the US Food and Drug Administration (FDA) has granted premarket approval (PMA) of the Trilogy transcatheter heart valve (THV) system for the treatment of patients with symptomatic, severe aortic regurgitation (AR) who are at high or greater risk for surgical aortic valve replacement (SAVR). This approval makes the Trilogy THV system the first and only transcatheter device in the U…

FDA Approves JenaValve’s Trilogy THV System for Symptomatic, Severe Aortic Regurgitation

March 18, 2026—JenaValve Technology, Inc., announced FDA premarket approval of the Trilogy transcatheter heart valve (THV) system for the treatment of patients with symptomatic, severe aortic regurgitation who are at high or greater risk for surgical aortic valve replacement. According to the company, the PMA approval is supported by successful results from the ALIGN-AR pivotal trial. The prospective, multicenter, single-arm investigational devi…

JenaValve strikes US market first with approval in TAVR-AR indication

The FDA PMA for JenaValve's Trilogy device for TAVR-AR comes months after a court struck down Edwards Lifesciences attempt to buy the company.The post JenaValve strikes US market first with approval in TAVR-AR indication appeared first on Medical Device Network.