JenaValve has announced promising results from an expanded cohort of 500 patients in the ALIGN-AR pivotal trial, evaluating its Trilogy transcatheter heart valve (THV) system for treating severe aortic regurgitation (AR). This represents the largest prospective study of transcatheter aortic valve replacement (TAVR) for AR to date.
Currently, TAVR is primarily used for aortic stenosis (AS), but FDA approval for AR—expected by late 2025, according to GlobalData—could expand treatment options for an underserved population. Approval would also bolster Edwards’ market position following its $1.2 billion acquisition of JenaValve and Endotronix last year.
The latest analysis showed a 30-day primary safety endpoint of 26.2%, significantly below the non-inferiority margin of 40.5%, and a one-year mortality rate of just 8.1%, well under the 25% benchmark.
“These expanded data demonstrate consistent performance of the Trilogy System, potentially offering severe aortic regurgitation patients, who are poor surgical candidates, a path to life-saving treatment,” said JenaValve CEO John Kilcoyne.
Follow MEDWIRE.AI for more updates on TAVR advancements.
