FDA approves JenaValve Trilogy transcatheter heart valve for aortic regurgitation

May 7, 2026
Source: ASM International

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JenaValve Technology, Irvine, California, received U.S. Food and Drug Administration approval on March 23, 2026 for the Trilogy Heart Valve System for the treatment of symptomatic severe aortic regurgitation in patients deemed at high or greater risk for surgical aortic valve replacement. Trilogy is the first and only transcatheter heart valve approved in the United States for aortic regurgitation, addressing a long-standing unmet need in structural heart medicine.

The Trilogy device is a self-expanding, transcatheter aortic valve implant built on a low-profile nitinol frame with porcine pericardial tissue leaflets. The device’s locator architecture is designed to engage the native aortic leaflets to provide secure anchoring in regurgitant anatomy that lacks the calcified landing zone typically used for transcatheter valves indicated for aortic stenosis.

The approval is supported by the ALIGN-AR pivotal trial, which evaluated Trilogy in patients with symptomatic severe aortic regurgitation at prohibitive or high surgical risk. The trial demonstrated meaningful reductions in regurgitation severity at one year alongside acceptable safety endpoints, providing the first prospective evidence base for a dedicated AR transcatheter device in the United States.

JenaValve Technology develops transcatheter heart valve systems for the treatment of aortic regurgitation and aortic stenosis. The company is privately held and headquartered in Irvine, California.

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