JenaValve Wins FDA Approval for First AR-Specific Transcatheter Valve

JenaValve has received premarket approval from the U.S. Food and Drug Administration for its Trilogy transcatheter heart valve to treat patients with severe, symptomatic aortic regurgitation who are at high surgical risk.

The Trilogy system is the first transcatheter valve specifically approved for this condition, addressing a major unmet need. Aortic regurgitation occurs when the valve fails to close properly, allowing blood to flow backward into the heart and potentially leading to serious complications.

Approval was supported by data from the ALIGN-AR trial, which demonstrated the device’s safety and effectiveness. The valve features a unique design with locators that anchor to native valve leaflets, enabling accurate placement during implantation.

The decision follows a blocked acquisition attempt by Edwards Lifesciences, after regulatory concerns over market competition.

JenaValve plans to launch the device in the U.S., initially targeting clinical trial sites before expanding to additional hospitals.

20-03-2026