JenaValve presents LVAD and pacemaker data for Trilogy TAVR system
JenaValve Technology presented two late-breaking clinical datasets at the New York Valves 2026 conference this week, offering fresh evidence on the performance of its Trilogy Transcatheter Heart Valve (THV) System in patients with aortic regurgitation (AR), including a particularly high-risk cohort receiving left ventricular assist devices (LVADs).
The Irvine, California-based company also hosted a live case broadcast of a Trilogy implant in a patient with pure native AR, alongside multiple AR-focused sessions examining left ventricular remodelling trajectories following treatment.
Pacemaker predictors in AR patients
The first late-breaking presentation, delivered by James McCabe, MD, of Beth Israel Deaconess Medical Center, examined pacemaker implantation rates following transcatheter aortic valve replacement (TAVR) in AR patients, drawing on data from the ALIGN-AR study. The analysis found that the factors predicting pacemaker need in AR patients differ from those seen in aortic stenosis (AS) cases, where device oversizing is the more typical driver.
McCabe said the findings reinforce that AR "is a distinct entity separate from AS" and that clinical management must adapt accordingly. The distinction has practical implications for patient selection and procedural planning, as AR patients have a different underlying haemodynamic burden than those with stenotic disease.
LVAD outcomes and the JENA-VAD Registry
The second presentation, from Ravi Ramana, DO, of Heart Care Centers of Illinois and the national principal investigator of the prospective JENA-VAD Registry, focused on a retrospective analysis of 28 LVAD patients treated with Trilogy under US Expanded Access provisions, covering both compassionate and emergency use.
Patients on continuous-flow LVADs who develop significant AR have very limited treatment options and typically face poor outcomes. In this retrospective cohort, Trilogy demonstrated high procedural success and low 30-day mortality, with no major complications reported. One-year mortality was 7.3%, a figure Ramana described as encouraging given the complexity of the population treated.
Ramana noted that the results "begin to lay the foundation for a much-needed option for these patients," though he was careful to frame them as early-stage evidence rather than definitive proof of clinical benefit. The prospective JENA-VAD Registry, an IDE study sponsored by JenaValve, is continuing to enrol patients to build a more rigorous evidence base.
Market context and regulatory positioning
The structural heart disease market is dominated by large-volume TAVR players targeting aortic stenosis, and the AR indication remains comparatively underserved at a global level. JenaValve's Trilogy holds regulatory approvals in both the United States and Europe for AR and AS in high-surgical-risk patients, giving it a regulatory foothold that few competitors can yet match in the pure AR space.
The LVAD-plus-AR population represents a particularly acute unmet need: patients on mechanical circulatory support frequently develop AR as a consequence of device-related physiology, and standard surgical options carry prohibitive risk. Positive registry data, if the prospective JENA-VAD study bears out the early retrospective signals, could support a dedicated labelling expansion or reimbursement argument in several markets.
JenaValve is backed by a broad syndicate including Bain Capital Life Sciences, the Qatar Investment Authority, and Cormorant Asset Management, suggesting the company has the capital to continue its clinical programme through the registry's completion. Investors will be watching for prospective JENA-VAD readouts as the next significant evidence milestone.