FDA Approves JenaValve's Trilogy Transcatheter Valve for Aortic Regurgitation

The US Food and Drug Administration has granted premarket approval to JenaValve Technology's Trilogy Transcatheter Heart Valve System for patients with symptomatic, severe aortic regurgitation who are at high or greater risk for surgical aortic valve replacement, the Irvine, California, company announced on March 18.

JenaValve said Trilogy is "the first and only transcatheter device in the United States with a dedicated indication for eligible patients." That is the company's description.

What the FDA approved

The FDA's PMA database lists P250024 for the Trilogy Transcatheter Heart Valve System, received June 30, 2025, with a decision date of March 17, 2026. The approved indication covers symptomatic, severe native tricuspid aortic valve regurgitation, not due to acute endocarditis, rheumatic heart disease or acute aortic dissection, in patients a heart team including a cardiac surgeon judges to be at high or greater surgical risk, defined as a predicted 30-day surgical mortality of at least 8%.

According to the FDA's Summary of Safety and Effectiveness Data, approval was based on ALIGN-AR, a prospective, multicenter, single-arm study run under an investigational device exemption. The PMA database included 180 patients treated between July 2018 and August 2022 at 20 US sites.

The 30-day composite safety endpoint, which counted death, stroke, major bleeding, kidney injury, major vascular complications, new pacemakers and other events, occurred in 26.7% of patients, below a pre-specified performance goal of 40.5%. The summary says "the most common event within 30-days was new permanent pacemaker implantation in 36/150 (24.0%) of subjects without prior pacemakers." One-year all-cause mortality, the primary effectiveness endpoint, was 6.2%, below a performance goal of 25% drawn from reported mortality in medically managed patients. At one year, 88.7% of evaluated patients had no or trace aortic regurgitation, the summary says.

Device and launch plans

JenaValve said the system uses three radiopaque locators that attach to the native aortic leaflets, allowing anchoring in valves that often lack the calcium conventional transcatheter valves rely on, and a nitinol frame designed to preserve future coronary access.

"For too long, high-risk AR patients were left with limited options," Chief Executive John Kilcoyne said in the release. Martin Leon of Columbia University Irving Medical Center, the trial's global program chair, said the locator design "addresses the fundamental challenge that has made AR so difficult to treat."

The company said it intends to begin launch activity immediately with participating clinical study sites, followed by new hospitals, Cardiac Interventions Today reported. Trilogy received CE Mark approval in Europe in 2021, according to the report.