JenaValve’s Trilogy THV System for Symptomatic, Severe AR Launched in the United States 

April 1, 2026—JenaValve Technology, Inc. announced the United States launch of the Trilogy transcatheter heart valve (THV) system. The first commercial transcatheter aortic valve replacement (TAVR) procedures with the device in the United States were performed by Torsten Vahl, MD, at NewYork-Presbyterian/Columbia University Irving Medical Center in New York, New York; Raj Makkar, MD, at Cedars-Sinai Medical Center in Los Angeles, California; and Vinod Thourani, MD, at Piedmont Heart Institute in Atlanta, Georgia.

On March 18, 2026, the company announced FDA premarket approval of the Trilogy THV system for the treatment of patients with symptomatic, severe aortic regurgitation (AR) who are at high or greater risk for surgical aortic valve replacement. The approval was supported by successful results from the ALIGN-AR pivotal trial.

Dr. Vahl and Dr. Thourani, who are the national Principal Investigators of the ALIGN-AR trial, and Dr. Makkar, who is the highest enroller in the trial, commented on the Trilogy THV device in the JenaValve press release.

“It is an honor to have been on this journey with Trilogy from the very first implants of the ALIGN-AR trial to FDA approval and the very first commercial implants,” stated Dr. Vahl. “This is a significant achievement for the field and more importantly, for the many thousands of high-risk AR patients that finally have TAVR available as an option to them.”

Dr. Thourani added, “We finally have the option of TAVR for AR patients at high-risk of surgery. I am excited for what this means for the future of AR treatment because this now opens the door to whether or not we expand this treatment beyond high-risk patients. The randomized ARTIST trial, which we are enrolling now, will give us the critical answers to that question.”

Finally, Dr. Makkar stated, “These first cases are a defining moment for the many Americans who have been suffering from severe AR. I have seen firsthand how many patients need a dedicated treatment option like Trilogy. With this groundbreaking FDA approval and commercial launch, I believe we will soon gain a clearer understanding of how many patients can truly benefit from this important therapy.”

In Europe, the Trilogy THV system received CE Mark approval in 2021.