JenaValve announced today that it published new results supporting the use of its transcatheter aortic valve replacement (TAVR) system.
The company published results from its ALIGN-AR pivotal trial in The Lancet. The trial evaluates the Trilogy valve in high-risk patients with symptomatic moderate-to-severe or severe aortic regurgitation. JenaValve presented positive study results from ALIGN-AR last fall at TCT 2023.
Trilogy met the non-inferiority criteria for its primary safety endpoint and primary efficacy endpoint in the study. Investigators concluded that it showed a high technical success rate and promising safety profile. They also observed low morbidity and mortality at one-year follow-up.
Other conclusions included favorable hemodynamics, low mean gradients and paravalvular leaks (PVLs) and significant clinical improvement. JenaValve reported substantial improvements in patient-reported outcomes and left ventricular remodeling as well.
ALIGN-AR serves as JenaValve’s FDA investigational device exemption (IDE) study intended to support premarket approval with the FDA. If approved, the company says Trilogy would become the first and only TAVR system authorized to treat symptomatic severe AR.
“I am proud of the patients, investigators, JenaValve staff, and countless others who helped achieve this extraordinary milestone in expanding transcatheter therapies for patients with aortic regurgitation. The positive outcomes reported from the ALIGN-AR trial in The Lancet usher in a new era for these patients,” said Dr. Duane Pinto chief medical officer at JenaValve.
