JenaValve wins FDA approval in severe aortic regurgitation

JenaValve has won FDA premarket approval for its Trilogy Transcatheter Heart Valve System, giving the company the first FDA-approved transcatheter device specifically indicated for symptomatic, severe native tricuspid aortic regurgitation in patients deemed by a Heart Team to be at high or greater surgical risk. The approval, announced March 18, 2026, is backed by data from the ALIGN-AR pivotal trial and creates an on-label option in a disease area where U.S. clinicians previously had no dedicated transcatheter therapy. FDA labeling says the indication excludes cases caused by acute endocarditis, rheumatic heart disease, or acute aortic dissection. (accessdata.fda.gov)

Why it matters: For veterinary professionals tracking device regulation, this is a notable example of FDA opening a new category based on a purpose-built platform rather than continued off-label use of devices designed for another indication. In ALIGN-AR, the Trilogy system achieved 91.9% one-year survival, a 96.4% device success rate, and low residual regurgitation, supporting the argument that dedicated device design can address anatomical problems that standard TAVR systems struggle with in aortic regurgitation. JenaValve’s platform uses radiopaque locators to attach directly to native aortic leaflets without relying on calcification, a design intended to support stable implantation, precise alignment, reduced paravalvular regurgitation, and preservation of future coronary access through its open-cell nitinol frame. (acc.org; pharmashots.com)

What to watch: JenaValve says it will begin launch activity immediately at participating study sites before expanding to hospitals across the U.S., while the ARTIST trial is already underway to compare Trilogy directly with surgical aortic valve replacement in broader AR populations. (jenavalve.com; pharmashots.com)