JenaValve wins FDA approval for Trilogy in severe aortic regurgitation
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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)
CURRENT FULL VERSION: JenaValve has secured FDA premarket approval for its Trilogy Transcatheter Heart Valve System in patients with symptomatic, severe aortic regurgitation who are at high or greater surgical risk, giving the US market its first dedicated transcatheter option for this disease. The company announced the decision on March 18, 2026, and said the approval makes Trilogy the first and only transcatheter device in the country specifically approved for symptomatic, severe aortic regurgitation. (globenewswire.com)
That’s a significant regulatory step because aortic regurgitation has remained a difficult gap in structural heart care. Surgical aortic valve replacement has been the recommended intervention for severe native disease, but many patients are poor surgical candidates. Conventional TAVR systems were built mainly for calcific aortic stenosis, and in pure aortic regurgitation they’ve faced technical limitations, especially because the native valve often lacks the annular calcium that helps standard devices anchor securely. (pubmed.ncbi.nlm.nih.gov)
The FDA decision rests on the ALIGN-AR program. In the pivotal cohort published in The Lancet in April 2024, 180 high-risk patients with symptomatic moderate-to-severe or severe native aortic regurgitation were treated with Trilogy. Technical success was achieved in 95% of patients, the 30-day primary safety endpoint met its prespecified noninferiority target, and 1-year mortality was 7.8%, also meeting the study’s primary efficacy benchmark. Investigators also reported evidence of favorable left ventricular remodeling, suggesting physiologic benefit beyond procedural success. (pubmed.ncbi.nlm.nih.gov)
More recent data presented at ACC.25 extended that picture. In 500 treated patients enrolled from 2018 through 2024, investigators reported 91.9% one-year survival, 96.4% device success, and more than mild residual regurgitation in just 1.5% of patients at 30 days. Valve embolization was reported in 1.6%, and 30-day mortality was lower in the continued-access cohort than in the original PMA cohort, which investigators attributed in part to better patient selection and procedural refinement over time. (acc.org)
The device’s design is central to why the approval matters. JenaValve says Trilogy was purpose-built for aortic regurgitation and uses three radiopaque locators that attach to the native aortic leaflets, allowing implantation even when calcium is absent. That feature directly addresses one of the main reasons off-label TAVR has been challenging in this population. In company materials, Martin Leon of Columbia described the approval as answering a long-standing question about whether severe aortic regurgitation can be treated safely and effectively with a transcatheter device, while Raj Makkar of Cedars-Sinai said updated trial data showed strong hemodynamics, low leakage, and meaningful quality-of-life improvement. (globenewswire.com)
There are still caveats. The pivotal evidence base is single-arm, company-funded, and focused on patients at high or greater surgical risk rather than the broader aortic regurgitation population. Pacemaker implantation remains an important issue: in the original Lancet report, 24% of patients required a new pacemaker, and ACC’s 2025 update said investigators were still exploring procedural or design changes that could reduce that burden. That means the approval is a breakthrough, but not the endpoint of the evidence story. (pubmed.ncbi.nlm.nih.gov)
The approval also fits into a wider pattern in cardiovascular regulation, where FDA decisions are increasingly spanning both implantable devices and software-based diagnostics. One recent example is Anumana’s 510(k) clearance for an AI-enabled pulmonary hypertension algorithm designed to detect early signs of PH from standard 12-lead ECGs. According to company-reported data summarized by PharmaShots, the software was developed using more than 250,000 Mayo Clinic patient records, can integrate with EHR and ECG management systems, and runs entirely within the health system environment without transferring patient data. In a 21,066-patient multicenter US study, it showed 73% sensitivity and 74.4% specificity; in a separate real-world analysis, it identified more than 85% of pulmonary arterial hypertension cases and 78% of chronic thromboembolic pulmonary hypertension cases using ECGs obtained between symptom onset and diagnosis. That’s a different product category and clinical target, but it reinforces the same broader theme: cardiovascular innovation is moving both toward more tailored interventions and earlier, data-driven detection.
Why it matters: For veterinary professionals, especially those watching cardiovascular device development, FDA decision-making, and translational medtech, Trilogy’s approval is a useful case study in how device makers can win a first-in-category indication by designing around a specific anatomical problem rather than extending a platform built for another disease. It also shows how a single-arm pivotal trial can support approval in an area of unmet need when the target population is narrowly defined and existing options are limited. More broadly, it signals continued momentum in structural heart innovation around regurgitant valve disease, where dedicated devices are moving from feasibility to commercialization, while adjacent clearances such as Anumana’s show the agency is also opening doors for software-as-a-medical-device tools aimed at earlier cardiovascular detection. (globenewswire.com)
What to watch: JenaValve says it plans an immediate launch at participating clinical study sites before expanding to additional hospitals, and the next milestones will likely include post-approval adoption, reimbursement execution, and randomized evidence from the ARTIST study comparing Trilogy-based TAVR with surgery in operable patients. In parallel, the commercial and clinical uptake of cleared cardiovascular AI tools will be worth watching too, especially products that plug into existing ECG workflows and keep data inside the health system, because those implementation details often determine whether promising algorithms become routine care. (globenewswire.com)