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 addressing an unmet need for patients suffering from significant AR,” said Dr. Martin B. Leon global program chair for the trial. “The unique design of the Trilogy System has the potential to address the shortcomings of existing TAVR devices when treating high surgical risk AR patients, enabling physicians to address a critical and long-overdue need for a minimally invasive solution that can meaningfully improve a patient’s quality of life.”
JenaValve’s “game-changing” technology
Dr. Raj Makkar is the leading enroller and VP of cardiac interventions and innovation at Cedars-Sinai Medical Center. He called the trial a potential game-changer. He said that, if approved, Trilogy represents the only transcatheter device indicated for ssAR patients.
“I am thrilled to see enrollment completed in this first-of-its-kind study. This milestone is a significant step towards our goal of helping ssAR patients with the Trilogy System,” said John Kilcoyne, JenaValve’s CEO. “We are grateful for the diligence and support of all who have enabled us to reach this point.”