JenaValve announced that it received FDA premarket approval (PMA) for its Trilogy THV system.
Trilogy, a transcatheter heart valve (THV) system, won approval for the treatment of patients with symptomatic, severe aortic regurgitation (AR) at high or greater risk for surgical aortic valve replacement (SAVR).
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Trilogy is now 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. Trilogy is already available in Europe.
Irvine, California-based JenaValve supported its PMA with results from the ALIGN-AR pivotal trial. The FDA investigational device exemption (IDE) trial demonstrated the safety and efficacy of Trilogy.
JenaValve now plans to begin launch activity for Trilogy immediately, starting with participating clinical study sites. It then plans to expand to new hospitals across the U.S.
“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,” JenaValve CEO John Kilcoyne said. “For too long, high-risk AR patients were left with limited options. Our Trilogy valve changes that reality. Today marks the beginning of a new era in the treatment of aortic regurgitation in America, and we are grateful to the FDA, our investigators, the patients who participated in our clinical program, our investors and the entire JenaValve team whose years of extraordinary commitment made this possible.”
The long-awaited approval for Trilogy at one point looked set to provide a boost to Edwards, which agreed to acquire JenaValve for $1.2 billion in 2024. However, JenaValve will be moving forward with the valve itself after the deal fell through at the start of 2026.
In August 2025, the FTC sued to stop the deal from taking place, claiming the acquisition was anti-competitive. The FTC alleged that Edwards and JenaValve represented the only two companies in the U.S. evaluating their transcatheter aortic valve replacement (TAVR) technology for the treatment of AR.
Then, in January, Edwards announced that it would not go through with the JenaValve acquisition after a federal judge granted the FTC a preliminary injunction to halt the deal.
As JenaValve takes Trilogy to the market, Edwards continues the development of its Sojourn transcatheter valve for AR. Edwards is currently enrolling patients in the JOURNEY pivotal trial for the J-Valve system it acquired from JC Medical.
While major TAVR systems, such as Edwards Lifesciences’ Sapien valves and Medtronic’s Evolut valves, are primarily used to treat aortic stenosis (narrowing of the valve), Trilogy was designed for aortic regurgitation (a leaky valve).
The Trilogy system’s locator technology is meant to ensure commissural alignment, allowing the valve to attach to the native leaflets for secure anchoring, even in the absence of calcium. The locators go within the native cusps and resist ventricular migration.
Other Trilogy features include 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.
