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JenaValve Launches Trilogy Transcatheter Heart Valve in the U.S.
The first and only FDA-approved device for severe aortic regurgitation
Apr. 2, 2026 at 5:21am
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JenaValve Technology, Inc. has announced the successful first cases and commercial launch of its Trilogy Transcatheter Heart Valve (THV) System in the United States. The Trilogy THV System is the first and only transcatheter device in the U.S. approved for the treatment of patients with symptomatic, severe aortic regurgitation who are at high or greater risk for surgical aortic valve replacement.
Why it matters
Aortic regurgitation is a historically underserved and underdiagnosed patient population that, until now, had no approved transcatheter treatment option. The Trilogy THV System provides a minimally invasive solution for high-risk AR patients, transforming how this condition is identified, diagnosed, and treated.
The details
The Trilogy THV System features three proprietary radiopaque locators that attach directly to the native aortic leaflets, enabling secure and stable implantation even in the absence of calcium. The locators also provide commissural alignment for precise valve positioning and ensure a reliable seal to minimize paravalvular regurgitation. The system's large, open-cell nitinol frame is designed to preserve future coronary access.
- The Trilogy THV System received CE Mark approval in 2021.
- The first commercial U.S. procedures were performed simultaneously on April 1, 2026.
The players
JenaValve Technology, Inc.
The developer and manufacturer of the Trilogy Transcatheter Heart Valve System.
Dr. Torsten Vahl
Director of translational research and interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center and national PI of the ALIGN-AR trial.
Dr. Raj Makkar
Cardiologist at Cedars-Sinai Medical Center and highest enroller in the ALIGN-AR trial.
Dr. Vinod H. Thourani
Chairman of Cardiovascular Surgery at Piedmont Heart Institute and national PI of the ALIGN-AR trial.
Peter Spadaro
Chief Commercial Officer of JenaValve.
What they’re saying
“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. 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. Torsten Vahl, Director of translational research and interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center and national PI of the ALIGN-AR trial
“These first cases are a defining moment for the many Americans who have been suffering from severe aortic regurgitation. 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.”
— Dr. Raj Makkar, Cardiologist at Cedars-Sinai Medical Center
“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.”
— Dr. Vinod H. Thourani, Chairman of Cardiovascular Surgery at Piedmont Heart Institute and national PI of the ALIGN-AR trial
“The commercial launch of Trilogy in the United States is the beginning of a transformation in how we identify, diagnose, and treat aortic regurgitation. We have assembled a world-class commercial organization to introduce the Trilogy valve to hospitals throughout the country to ensure patients have access to this therapy. The unmet need is enormous, and we are already experiencing strong demand. We are committed to reaching every patient who can benefit from the Trilogy System, while prioritizing patient outcomes and safety as we expand access to this game changing technology.”
— Peter Spadaro, Chief Commercial Officer of JenaValve
What’s next
The randomized ARTIST trial is currently enrolling patients to determine if the Trilogy THV System can be expanded beyond high-risk patients.
The takeaway
The launch of the Trilogy THV System represents a major breakthrough in the treatment of severe aortic regurgitation, providing a minimally invasive option for a historically underserved patient population. This new therapy has the potential to transform the standard of care and improve outcomes for thousands of Americans suffering from this debilitating condition.
