JenaValve announced today that it successfully completed patient enrollment in a trial evaluating its Trilogy heart valve system.
Irvine, California-based JenaValve develops and manufactures differentiated transcatheter aortic valve replacement (TAVR) systems. It designed Trilogy for high surgical risk patients with symptomatic, severe aortic regurgitation (AR).
JenaValve’s prospective, single-arm ALIGN-AR trial is operating under FDA investigational device exemption. The company designed the trial to assess the Trilogy heart valve system in high-risk patients with symptomatic, severe aortic regurgitation (ssAR).
Last week, the company closed a $100 million Series C financing round. It said it planned to use proceeds to complete its IDE trial for Trilogy. It plans to use results to support a future premarket approval (PMA) submission to the FDA.
“Completing the ALIGN-AR trial is a significant step forward for the cardiology community in addr…