JenaValve wins FDA approval for Trilogy in severe aortic regurgitation
CURRENT BRIEF VERSION: JenaValve said on March 18, 2026, that the FDA granted premarket approval for its Trilogy Transcatheter Heart Valve System for patients with symptomatic, severe aortic regurgitation who are at high or greater risk for surgical aortic valve replacement. The company says Trilogy is the first and only transcatheter device in the US with a dedicated indication for this population, a notable shift in a disease area where surgery has been the standard and transcatheter options have largely been off-label or unavailable. The approval was backed by the ALIGN-AR pivotal trial, which evaluated the device in high-surgical-risk patients with symptomatic native aortic regurgitation. (globenewswire.com)
Why it matters: For veterinary professionals tracking medtech regulation and translational cardiovascular innovation, this is a meaningful FDA milestone because it opens a minimally invasive treatment pathway for aortic regurgitation, a setting that has historically been harder to address with transcatheter valves because these patients often lack the calcification that helps anchor conventional TAVR devices. Trilogy was designed around that problem, using leaflet locators rather than relying on calcium for fixation. In the 180-patient pivotal ALIGN-AR cohort published in The Lancet, the study met its primary safety and efficacy goals, with 1-year mortality of 7.8%; updated ACC 2025 data in 500 patients showed 91.9% one-year survival, 96.4% device success, and low residual regurgitation, although pacemaker implantation remained a notable tradeoff at nearly one-quarter of patients. The approval also lands amid broader FDA movement in cardiovascular software and devices, including 510(k) clearance for Anumana’s ECG-AI pulmonary hypertension algorithm, a software tool for standard 12-lead ECGs that was developed on more than 250,000 Mayo Clinic records and reported 73% sensitivity and 74.4% specificity in a 21,066-patient multicenter study. (pubmed.ncbi.nlm.nih.gov)
What to watch: JenaValve says it will begin launch activity immediately at participating study sites, while the next major question is whether post-approval uptake, reimbursement, and future randomized data, including surgery-versus-TAVR comparisons, broaden use beyond today’s high-risk population. More broadly, cardiovascular innovation is also moving toward earlier, software-enabled detection: Anumana says its cleared pulmonary hypertension algorithm integrates with EHR and ECG management systems and runs within the health system environment without transferring patient data, underscoring how device and diagnostic regulation are advancing in parallel. (globenewswire.com)