The U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) to JenaValve Technology, Inc. for its Trilogy THV System for the treatment of patients with symptomatic, severe AR who are at high or greater risk for surgical aortic valve replacement (SAVR). According to a company press release, the approval marks the first and only transcatheter device in the U.S. with a dedicated indication for eligible patients.

JenaValve CEO, John Kilcoyne, call the approval “a defining moment for JenaValve.” and suggested high-risk AR patients in the United States have suffered too long from severe aortic regurgitation with nowhere to turn. “Our Trilogy valve changes that reality,” Kilcoyne stated. “Today marks the beginning of a new era in the treatment of aortic regurgitation in America.”

The PMA approval is supported by results from the ALIGN-AR Pivotal Trial, a prospective, multicenter, single-arm Investigational Device Exemption (IDE) study which assessed the safety and efficacy of the Trilogy THV System in high-surgical-risk patients with symptomatic, severe AR. JenaValve now intends to commence launch activity for the Trilogy System immediately with participating clinical study sites, followed by new hospitals across the country.

“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? The answer is yes.” said Martin B. Leon, MD, Professor of Medicine and Director of the Center for Interventional Vascular Therapy at Columbia University Irving Medical Center/New York-Presbyterian Hospital, and Global Program Chair of the ALIGN-AR Trial. “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.”

The Trilogy THV System is the first and only transcatheter heart valve in the United States indicated for native, symptomatic, severe aortic regurgitation in patients who are judged by a Heart Team to be at high or greater risk for surgical aortic valve replacement.

The Trilogy System was developed for the unique anatomical challenges of aortic regurgitation. Unlike conventional TAVR valves that rely on annular calcification for anchoring — which is typically absent in AR patients — the Trilogy System features three proprietary radiopaque locators that attach directly to the native aortic leaflets, enabling secure and stable implantation even in the absence of calcium. The locators also provide commissural alignment for precise valve positioning and ensure a reliable seal to minimize paravalvular regurgitation. The system’s large, open-cell nitinol frame is designed to preserve future coronary access.