FDA Approves JenaValve’s Trilogy for Aortic Regurgitation

The US Food and Drug Administration has approved the Trilogy transcatheter heart valve (JenaValve) for patients with symptomatic severe aortic regurgitation at high risk for surgery, according to an announcement from the manufacturer last week.

The FDA approval, which is based on results from ALIGN-AR, makes the device the first approved for this patient population.

ALIGN-AR investigated the safety and efficacy of the device in patients at high risk for complications or death during surgical aortic valve replacement. In the trial, treatment with the Trilogy transcatheter heart valve met the preestablished safety and efficacy thresholds. Follow-up at 2 years showed the device continued to perform well, with excellent hemodynamics and low rates of paravalvular leak.

Trilogy, which received CE Mark approval in Europe for AR and aortic stenosis in 2021, is specifically designed for patients with AR. These patients typically lack calcification in and around the annulus, a feature that makes it challenging to anchor transcatheter heart valves developed to treat aortic stenosis.

The Trilogy valve is designed with three radiopaque markers that go with the aortic sinuses, and after alignment with native cusps, attach directly onto the leaflets. The valve has an open-cell nitinol frame to preserve future coronary access.

Edwards Lifesciences tried to acquire JenaValve and the Trilogy valve in 2024 but was blocked by the US Federal Trade Commission because the acquisition was deemed anticompetitive. Edwards is currently enrolling patients in the JOURNEY trial with the J-valve designed specifically for AR in patients at high risk for surgery.