JenaValve Reaches Milestone in ALIGN-AR Trial Enrollment of Trilogy TAVR System

June 15, 2021—JenaValve Technology, Inc., developer of a transcatheter aortic valve replacement (TAVR) system, announced a milestone in enrollment for its ALIGN-AR clinical trial of the company’s Trilogy heart valve system. The 100th patient was enrolled in the prospective, multicenter clinical trial that is evaluating the device in the treatment of symptomatic, severe high-surgical-risk aortic regurgitation (AR) patients.

On May 25, the company announced that it had received CE Mark approval for its transfemoral Trilogy TAVR system for the treatment of severe, symptomatic AR and aortic stenosis in patients at high surgical risk. The system is available in three sizes, enabling the treatment of a broad range of annular diameters.

Martin Leon, MD, who is Global Program Chair for the ALIGN-AR trial, commented in JenaValve’s announcement, “The enrollment of the 100th patient in the ALIGN-AR trial is a significant milestone toward the ultimate goal of making Trilogy TAVR system available to high-surgical-risk AR patients. The sites participating in the ALIGN-AR study across the United States and Europe are committed to the clinical program required to provide safety and effectiveness evidence for these high-risk patients with AR.”

Torsten Vahl, MD, stated in the JenaValve press release, “With the Trilogy valve, I will have a TAVR option that is uniquely designed for the challenging anatomical characteristics of AR patients. As the ALIGN-AR trial Coprincipal Investigator, I am excited to lead and participate in the trial to make this device available to high-risk AR patients.”

Raj Makkar, MD, added, “I am pleased to be part of the ALIGN-AR trial as the hemodynamic effects of severe AR in high-risk patients are debilitating, and the current ALIGN-AR trial and Trilogy heart valve system provides us with a minimal invasive transfemoral medical procedure that has the potential to change the treatment paradigm for what I believe to be a vastly underdiagnosed and undertreated AR patient population.”