JenaValve’s Trilogy transcatheter aortic valve replacement device for severe aortic regurgitation (TAVR-AR) treatment has obtained pre-market approval (PMA) from the US Food and Drug Administration (FDA), making it the first device of its kind to treat the heart condition.
The designation distinguishes JenaValve’s Trilogy as the first TAVR device to be granted a dedicated indication in the US for treating eligible severe AR patients deemed to be at high or greater risk for surgical aortic valve replacement (SAVR). Trilogy previously gained a CE mark for TAVR-AR in Europe in 2021.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
With the PMA in hand, JenaValve said it intends to immediately commence launch activity for Trilogy with participating clinical study sites, followed by additional hospitals across the US.
“This FDA approval is the defining moment for JenaValve and, more importantly, those patients in the United States who have suffered from severe aortic regurgitation with nowhere to turn,” said JenaValve CEO John Kilcoyne.
Aortic regurgitation occurs when there is reverse blood flow through the aortic valve due to inadequate closure of the aortic valve during diastole, resulting in symptoms including shortness of breath, chest pain, and fatigue.
Kilcoyne continued: “For too long, high-risk AR patients were left with limited options. Our Trilogy valve changes that reality.”
JenaValve’s PMA approval was supported by data from the ALIGN-AR pivotal trial (NCT04415047), and Investigational Device Exemption (IDE) study that assessed the safety and efficacy of the Trilogy THV System in high-surgical-risk patients with symptomatic, severe AR.
In 180 high-risk patients with symptomatic, severe aortic regurgitation, Trilogy demonstrated effective orifice area (EOA), low transvalvular gradients, and low paravalvular regurgitation.
Martin B Leon, professor of medicine and director of the Center for Interventional Vascular Therapy at Columbia University Irving Medical Center and global programme chair of the ALIGN-AR trial, commented: “With what we have learned about the Trilogy valve from the ALIGN-AR trial, we now have the answer to a question that the cardiology community had struggled with – can we safely and effectively treat patients with severe aortic regurgitation with a transcatheter device? The answer is yes.”
Lucrative future for TAVR with AR addition
According to a GlobalData market model, the global TAVR market is growing at a CAGR of over 7% and is projected to reach a valuation of $13.8bn in 2035, up from almost $7bn in 2025. Meanwhile, GlobalData analysts previously posited that AR’s addition as a new TAVR indication (TAVR-AR) could potentially push the market’s CAGR into the double-digit range.
JenaValve’s efforts to become the first company with a TAVR-AR indication in the US had made the company an acquisition target for Edwards Lifesciences. Edwards outlaid $1.2bn to acquire the company alongside heart failure specialist Endotronix in July 2024.
However, in August 2025, the US Federal Trade Commission (FTC) sued Edwards to halt its planned acquisition of JenaValve. At the time, no TAVR devices with an AR indication were currently available on the US market, with JC Medical, which Edwards acquired in August 2024, and JenaValve the two companies farthest along in their devices’ clinical development.
With JC Medical now a subsidiary of Edwards, the FTC claimed the company’s acquisition of JenaValve stood to eliminate competition that has spurred innovation in the TAVR-AR space. The US District Court for the District of Columbia agreed with the FTC, approving its injunction motion in January 2026 and putting an end to Edwards planned acquisition of JenaValve.
Edwards disagreed with the court’s decision, emphasising that the acquisition would have been in the best interests of a “large, growing and underserved” patient population.
