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

JenaValve Announces FDA Approval of the Trilogy™ Transcatheter Heart Valve System — the First and Only Transcatheter Device Approved for Symptomatic, Severe Aortic Regurgitation (ssAR) in the United States

IRVINE, Calif., March 18, 2026 – 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 THV System for the treatment of patients with symptomatic, severe 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 United States with a dedicated indication for eligible patients. Symptomatic, severe AR is significantly undertreated and potentially life altering to the tens of thousands of people annually identified as having this disease in the United States alone.

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