FDA Approves JenaValve’s Trilogy THV System for Symptomatic, Severe Aortic Regurgitation

March 18, 2026—JenaValve Technology, Inc., announced FDA premarket approval of the Trilogy transcatheter heart valve (THV) system for the treatment of patients with symptomatic, severe aortic regurgitation who are at high or greater risk for surgical aortic valve replacement.

According to the company, the PMA approval is supported by successful results from the ALIGN-AR pivotal trial. The prospective, multicenter, single-arm investigational device exemption study assessed the safety and efficacy of the Trilogy THV system in high-surgical–risk patients with symptomatic, severe aortic regurgitation.

JenaValve intends to commence launch activity for the Trilogy system immediately with participating clinical study sites, followed by new hospitals across the country. In Europe, the Trilogy THV system received CE Mark approval in 2021.

Martin B. Leon, MD, serves as the Global Program Chair of the ALIGN-AR trial. Dr. Leon is Professor of Medicine and Director of the Center for Interventional Vascular Therapy at Columbia University Irving Medical Center/New York-Presbyterian Hospital in New York, New York.

“With what we have learned about the Trilogy valve from the ALIGN-AR trial, we now have the answer to a question that the cardiology community had struggled with—can we safely and effectively treat patients with severe aortic regurgitation with a transcatheter device?” commented Dr. Leon in JenaValve’s press release. “The answer is yes.”

Dr. Leon continued, “The unique design of the Trilogy system—with its locator technology providing secure anchoring even in the absence of calcium—addresses the fundamental challenge that has made AR so difficult to treat. This approval establishes a new standard of care for high-risk AR patients and is a landmark achievement for the field of interventional cardiology.”