JenaValve has secured the FDA’s approval for its minimally invasive heart implant, making it the first to claim a U.S. green light to treat severe backflow through the aortic valve.
And it gets to keep it all to itself. Over the past year and a half, the Trilogy transcatheter system was at the center of a near-billion-dollar acquisition play from rival valve maker Edwards Lifesciences—however, that deal was ultimately blocked by the Federal Trade Commission through a January court ruling.
The antitrust agency had argued that a takeover of JenaValve would have consolidated the development of TAVR implants for aortic regurgitation, as Edwards previously acquired JC Medical and its J-Valve implant through a $316 million deal in 2024.
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Though multiple TAVR systems have garnered the FDA’s blessing, they have all been aimed at treating aortic stenosis, where a narrowed and potentially calcified valve impedes the flow of blood. Until Trilogy’s green light, no minimally invasive devices had been approved for regurgitation, where the flaps of the valve fail to come together and form an incomplete seal.
In those cases, seating and anchoring a transcatheter implant can provide challenges, and the millions of people in the U.S. with the condition typically undergo open-heart surgery.
“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 in a statement.
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“For too long, high-risk AR patients were left with limited options. Our Trilogy valve changes that reality,” Kilcoyne added. “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 Irvine, California-based company said it plans to begin rolling out Trilogy immediately, starting with the U.S. sites that participated in its pivotal clinical trial, Align-AR. The aortic valve implant previously obtained approval in Europe in 2021—covering both stenosis and regurgitation—and has been used in more than 1,200 procedures on the continent.
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Trilogy is designed to attach directly to the native aortic leaflets, with or without hardened calcium deposits, with an open frame that allows for future access to the coronary arteries.
“The unique design of the Trilogy System—with its locator technology providing secure anchoring even in the absence of calcium—addresses the fundamental challenge that has made AR so difficult to treat,” said Martin Leon, M.D., global chair of the Align-AR trial and director of the Center for Interventional Vascular Therapy at Columbia University Irving Medical Center/New York-Presbyterian Hospital. “This approval establishes a new standard of care for high-risk AR patients and is a landmark achievement for the field of interventional cardiology.”
Last year, the single-arm Align-AR study showed the Trilogy implant met its safety and performance endpoints, with improvements in function and quality of life measures out to two years. Enrolling a total of 700 patients across two cohorts, its results were published in The Lancet and presented as a late-breaking trial at the PCR London Valves meeting last November.
