Trilogy, a transcatheter heart valve (THV) system, won FDA approval in March for the treatment of patients with symptomatic, severe aortic regurgitation (ssAR) at high or greater risk for surgical aortic valve replacement (SAVR).
With its approval, Trilogy became the first and only transcatheter device approved in the U.S. with a dedicated indication for this patient population. The company says symptomatic, severe AR remains significantly undertreated while posing a life-altering threat to patients. Other heart valve technologies, like those from Edwards and Medtronic, currently target aortic stenosis, a condition through which the valve narrows. AR, a leaky valve, now has a new treatment option through Trilogy.
Dr. Torsten Vahl, Dr. Raj Makkar and Dr. Vinod Thourani performed the first commercial U.S. procedures simultaneously. They took place at NewYork-Presbyterian/Columbia University Irving Medical Center, Cedars-Sinai Medical Center and Piedmont Heart Institute, respectively.
More about the Trilogy valve
JenaValve said Trilogy was purpose-built to address the unique anatomical challenges of AR. Unlike conventional TAVR valves that rely on annular calcification for anchoring, Trilogy uses other methods to treat AR, due to the typical absence of annular calcification.
Trilogy features locator technology that ensures commissural alignment. This allows the valve to attach to the native leaflets for secure anchoring. The locators go within the native cusps and resist ventricular migration.
JenaValve’s technology also features a self-expanding nitinol frame and porcine pericardial tissue with Jasmine proprietary tissue treatment. Trilogy has a large, open-cell design to enable future coronary access.
The valve has been used in more than 1,200 commercial procedures in Europe to date.
Edwards, a leader in the TAVR space, previously attempted to acquire JenaValve and its technology. However, the company abandoned the deal at the start of 2026 due to FTC scrutiny.
As JenaValve takes Trilogy to market, Edwards continues developing its Sojourn transcatheter valve for AR. It’s also currently enrolling patients in the JOURNEY pivotal trial for the J-Valve system it acquired from JC Medical.
Commentary from JenaValve leadership and doctors
Peter Spadaro, JenaValve CCO, said:
“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.”
Dr. Torsten Vahl said:
“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. Raj Makkar said:
“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. Vinod Thourani said:
“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.”
