JenaValve has received approval from the U.S. Food and Drug Administration for its Trilogy transcatheter heart valve system, marking the first minimally invasive device cleared in the United States to treat severe aortic regurgitation.
The decision establishes a new option for patients with this condition, where the aortic valve does not close properly, allowing blood to flow backward. Previously, transcatheter aortic valve replacement (TAVR) devices approved by regulators were limited to treating aortic stenosis, a separate condition involving narrowing and calcification of the valve.
In contrast, aortic regurgitation presents additional technical challenges, particularly in anchoring implants due to the absence of calcified structures. As a result, many patients in the U.S. have traditionally required open-heart surgery.
The approval follows a period of corporate interest in JenaValve’s technology. Over the past 18 months, the Trilogy system was involved in a proposed acquisition by Edwards Lifesciences, valued at nearly $1 billion. However, the deal was blocked after the Federal Trade Commission raised antitrust concerns, arguing that the acquisition would concentrate the development of TAVR therapies for aortic regurgitation. The agency pointed to Edwards’ prior $316 million acquisition of JC Medical and its J-Valve implant in 2024 as part of its case.
JenaValve’s Trilogy system is designed to attach directly to the native aortic valve leaflets, regardless of the presence of calcium deposits. Its structure includes an open-frame design, which allows for future access to the coronary arteries if needed. According to the company, this approach addresses a key limitation in treating regurgitation with transcatheter devices.
“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 John Kilcoyne, chief executive officer of JenaValve.
Kilcoyne added that patients considered high-risk had limited treatment options prior to this development and stated that the Trilogy system introduces a new approach to care. He also acknowledged the contributions of regulators, clinical investigators, trial participants, investors, and company staff in achieving the milestone.
The company, headquartered in Irvine, California, said it plans to begin deployment of the Trilogy system immediately. Initial availability will focus on U.S. medical centers that participated in the Align-AR pivotal clinical study.
Trilogy had previously secured regulatory approval in Europe in 2021, where it is indicated for both aortic stenosis and regurgitation. Since then, it has been used in more than 1,200 procedures across the region.
Clinical evidence supporting the FDA approval comes from the Align-AR trial, a single-arm study involving 700 patients across two cohorts. The study met its primary safety and effectiveness endpoints and demonstrated improvements in patient function and quality of life over a follow-up period of up to two years. Findings from the trial were published in The Lancet and presented as a late-breaking study at the PCR London Valves meeting last November.
Martin Leon, M.D., who served as global chair of the Align-AR trial and is affiliated with Columbia University Irving Medical Center and NewYork-Presbyterian Hospital, stated that the device’s locator technology enables secure placement even in cases lacking calcification, addressing a central difficulty in treating aortic regurgitation with minimally invasive methods.
Breakthrough for JenaValve Technology
The JenaValve Trilogy System is the first minimally invasive implant specifically designed to treat patients suffering from severe aortic regurgitation. Unlike traditional open-heart surgery, JenaValve offers a less invasive alternative, reducing recovery time and improving patient outcomes.
Addressing an Unmet Need
Severe aortic regurgitation has long lacked minimally invasive treatment options, making JenaValve a significant advancement. Many patients previously considered high-risk for surgery can now benefit from JenaValve technology.
How JenaValve Improves Patient Care
The JenaValve system is engineered to provide precise valve placement and improved hemodynamic performance. With JenaValve, physicians can deliver safer and more effective treatment, enhancing overall cardiac function.
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