JenaValve’s ALIGN-AR United States Pivotal Trial of Trilogy TAVR System Completes Enrollment

September 14, 2022—JenaValve Technology, Inc. announced the successful completion of patient enrollment in the ALIGN-AR pivotal trial of the company’s Trilogy transcatheter aortic valve replacement (TAVR) system.

According to JenaValve, ALIGN-AR is a landmark prospective, single-arm investigational device exemption trial designed to assess the safety and efficacy of the Trilogy system in high-risk patients with symptomatic, severe aortic regurgitation (ssAR). Results from the study are intended to support a future premarket approval submission to the FDA.

Martin B. Leon, MD, serves as Global Program Chair for the trial. Dr. Leon is Professor of Cardiology and Director, Center for Interventional Vascular Therapy at the Columbia University Irving Medical Center, NewYork-Presbyterian Hospital in New York, New York.

“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,” commented Dr. Leon in JenaValve’s press release. “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.”

Raj Makkar, MD, who is Vice-President, Cardiac Interventions and Innovation at Cedars-Sinai Medical Center in Los Angeles, California, is the leading enroller for the trial.

Dr. Makkar stated in the press release, “This is a potentially game-changing clinical trial for the treatment of ssAR in a significant patient population which has not been addressed by other solutions. If approved, the Trilogy system will be the only transcatheter device indicated for the treatment of ssAR patients, with a potential to become the standard of care for these patients.”

The Trilogy system received CE Mark approval in May 2021, providing European physicians a device with true dual-disease treatment capabilities, noted the company.

In January 2020, JenaValve received Breakthrough Device designation from the FDA to facilitate the review of ALIGN-AR.