FDA Approves Trilogy Transcatheter Valve for Severe Aortic Regurgitation

 In a major milestone for structural heart therapy, the U.S. Food and Drug Administration (FDA) has approved the Trilogy transcatheter heart valve (JenaValve Technology) for the treatment of symptomatic severe aortic regurgitation (AR) in patients at high risk for surgical valve replacement.

This FDA decision marks the first approved transcatheter heart valve specifically indicated for native aortic regurgitation, a condition historically difficult to treat with transcatheter techniques.

Evidence from the ALIGN-AR Trial

The approval is grounded in the pivotal ALIGN-AR trial, which assessed the safety and efficacy of the Trilogy valve in high-risk patients unsuitable for surgical aortic valve replacement.

The device met prespecified safety and performance endpoints, showing marked improvement in NYHA functional class, symptom relief, and excellent valve hemodynamics.

At two-year follow-up, outcomes remained strong — the valve demonstrated durable performance, low paravalvular leak rates, and sustained LV remodeling benefits, confirming its long-term clinical viability.

Innovative Design for Native AR

Patients with aortic regurgitation typically present a challenging anatomy due to the lack of annular or leaflet calcification, which prevents secure anchoring of conventional TAVR designs created for stenotic valves.

The Trilogy valve is uniquely engineered to address this limitation. Key design features include:

• Three radiopaque alignment markers to ensure precise positioning with the aortic sinuses and native cusps.

• A leaflet-clipping anchoring mechanism that attaches directly onto native leaflets, eliminating dependence on annular calcium.

• An open-cell nitinol frame that maintains radial strength, optimizes valve sealing, and preserves future coronary access — a critical consideration for younger and complex patients.

From Europe to the U.S. Approval

The Trilogy system received CE Mark approval in Europe in 2021 for both AR and AS indications. With its FDA approval in the U.S., it now provides interventional cardiologists a dedicated transcatheter option for this underserved valve population.

In a related development, Edwards Lifesciences’ 2024 attempt to acquire JenaValve and its Trilogy platform was blocked by the U.S. Federal Trade Commission (FTC) over antitrust concerns. Edwards has since advanced its own AR-targeted program — the J-valve — now enrolling patients in the JOURNEY trial.

Looking Ahead

The FDA approval of the Trilogy transcatheter valve opens a new era in transcatheter therapy for pure aortic regurgitation, a disease once limited to surgical intervention. This device offers a tailored, anatomically adaptive solution that could significantly broaden treatment options for high-risk patients.

As U.S. centers gain more experience, real-world outcomes, patient selection criteria, and imaging-guided implantation techniques will evolve — potentially redefining the transcatheter approach to AR in both high-risk and, eventually, intermediate-risk populations.