FDA Approves Trilogy Transcatheter Heart Valve System for Treating Severe Aortic Regurgitation

The FDA has approved the Trilogy Transcatheter Heart Valve System for treating patients with symptomatic severe aortic regurgitation . It is the first and only TAVR device specifically indicated for high-risk patients with this condition, offering a minimally invasive alternative to surgery. This approval makes the Trilogy THV System the first and only transcatheter device in the United States with a dedicated indication for eligible patients. Symptomatic, severe AR is significantly undertreated and potentially life altering to the tens of thousands of people annually identified as having this disease in the United States alone. The PMA approval is supported by successful 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. “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? 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.” “This FDA approval is the defining moment for JenaValve and, more importantly, those patients in the United States who have suffered from severe aortic regurgitation with nowhere to turn,” said John Kilcoyne, Chief Executive Officer of JenaValve. “For too long, high-risk AR patients were left with limited options. Our Trilogy valve changes that reality. Today marks the beginning of a new era in the treatment of aortic regurgitation in America, and we are grateful to the FDA, our investigators, the patients who participated in our clinical program, our investors and the entire JenaValve team whose years of extraordinary commitment made this possible.” JenaValve intends to commence launch activity for the Trilogy System immediately with participating clinical study sites, followed by new hospitals across the country. 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 purpose-built to address 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.