FDA approved JenaValve Technology's Trilogy Transcatheter Heart Valve System on March 17. The PMA, P250024, covers symptomatic, severe native aortic regurgitation in patients a heart team judges at high or greater surgical risk. It is the first transcatheter valve in the United States with a dedicated regurgitation indication. FDA received the application on June 30, 2025, so the review ran 260 days.
The approval rests on ALIGN-AR, a single-arm IDE study. The 180-patient primary cohort met its safety and effectiveness goals. Thirty-day mortality was 1.6%, and one-year all-cause mortality was 7.7% against a 25% performance benchmark. Technical success was 94.9%. A further 520 continued-access patients brought the dataset to 700, published in The Lancet and presented at PCR London Valves in November 2025.
The company got here without a buyer. Edwards Lifesciences agreed to acquire JenaValve for $1.2B in July 2024. The FTC sued in August 2024, arguing the two were the only companies developing TAVR for regurgitation. A federal judge in Washington granted a preliminary injunction on January 9, 2026. Edwards walked away the next day. JenaValve, backed by Bain Capital Life Sciences, Andera Partners and Valiance, will launch immediately at trial sites and then add hospitals nationwide.
An FTC merger challenge built on a device that had not yet been approved was unusual. The approval turns the agency's theory into a standalone competitor with its own price list.