JenaValve wins FDA approval in severe aortic regurgitation

JenaValve’s Trilogy Transcatheter Heart Valve System has secured FDA premarket approval, becoming the first and only transcatheter device in the U.S. with a dedicated indication for symptomatic, severe aortic regurgitation in high- or greater-risk surgical patients. The March 18, 2026 approval covers symptomatic, severe native tricuspid aortic valve regurgitation in patients judged by a Heart Team, including a cardiac surgeon, to face at least high risk from surgical aortic valve replacement. (accessdata.fda.gov)

That matters because aortic regurgitation has long been a difficult fit for transcatheter treatment. Conventional TAVR systems were developed mainly for aortic stenosis and typically rely on annular calcification for anchoring, a feature often absent in pure aortic regurgitation. Before this approval, U.S. physicians sometimes treated these patients off label, but there was no FDA-approved device specifically designed for the indication. Trilogy was built to address that gap with locator technology that attaches to native leaflets rather than depending on calcium for fixation. JenaValve has described the system’s radiopaque locators as supporting stable implantation and precise alignment, while the open-cell nitinol frame is intended to reduce paravalvular regurgitation and preserve future coronary access. (jenavalve.com; pharmashots.com)

The FDA’s PMA listing states that Trilogy is indicated for symptomatic, severe native tricuspid aortic valve regurgitation not due to acute endocarditis, rheumatic heart disease, or acute aortic dissection, in patients with predicted 30-day surgical mortality of at least 8% based on STS risk and other comorbidities not fully captured by the calculator. JenaValve has also said only physicians who complete its professional education training program are authorized to use the system, underscoring that commercialization will be tied closely to site training and controlled rollout. (accessdata.fda.gov)

Clinical evidence from ALIGN-AR was central to the approval. According to the American College of Cardiology, the trial enrolled 500 patients between 2018 and 2024, including both a premarket approval cohort and a continued access cohort. One-year survival was 91.9%, comfortably above the study’s prespecified threshold, device success was 96.4%, and more than mild residual regurgitation at 30 days was seen in just 1.5% of patients. Investigators also reported evidence of left ventricular reverse remodeling and improved quality of life, suggesting the device may do more than simply reduce leak in the short term. (acc.org)

Industry and clinician reaction has been notably positive. In JenaValve’s announcement, Martin Leon of Columbia said the field had struggled with whether severe aortic regurgitation could be treated safely and effectively with a transcatheter device, and that ALIGN-AR now supports a “yes.” Outside the company, TCTMD reported enthusiasm from interventional cardiologists reviewing the longer-term data, with Wayne Batchelor calling the therapy promising and Katherine Harrington highlighting the unmet need for an on-label valve for aortic insufficiency. (jenavalve.com)

Why it matters: For veterinary professionals and other readers following how FDA regulation shapes device markets, Trilogy is a useful case study in how purpose-built technology can unlock a new labeled use where adapted devices fell short. The approval may also influence payer coverage, hospital adoption, referral patterns, and training needs, because it moves treatment of severe AR from an off-label, case-by-case space toward a more standardized commercial pathway. More broadly, it shows how single-arm pivotal data can still support approval in high-risk populations when the unmet need is clear and the performance benchmark is clinically meaningful. The company has said launch will begin immediately through participating study sites before expanding to hospitals across the U.S., giving an early read on how quickly centers can operationalize training and adoption. (accessdata.fda.gov; pharmashots.com)

What to watch: Near term, watch the pace of JenaValve’s site rollout, starting with participating study centers and then broader hospital expansion, and whether high-volume valve centers move quickly to add trained operators. Longer term, the key milestone is the ARTIST randomized trial, which is comparing Trilogy with surgical aortic valve replacement and could determine whether the device expands beyond today’s high-risk population into a broader treatment setting. (jenavalve.com; pharmashots.com)