The FDA has approved JenaValve's Trilogy Transcatheter Heart Valve (THV) system for the treatment of patients with symptomatic severe aortic regurgitation who are at high or higher risk for aortic valve replacement surgery[1]. Trilogy is the first and only transcatheter device in the United States with a dedicated indication for this patient group[1]. The approval is based on the successful results of the ALIGN-AR study, which tested the safety and efficacy of the device in high-risk patients[1]. The study included an extended cohort of 700 patients and met the anticipated criteria for the primary safety and efficacy endpoints[5]. The Trilogy system has a unique design with locator technology that ensures secure anchoring even in the absence of calcium, which addressed a major challenge in the treatment of aortic regurgitation[1]. The device has already been used in Europe in more than 1,200 commercial procedures since obtaining the CE mark in 2021[1]. JenaValve plans to begin distribution of the Trilogy system immediately in participating clinical centers and subsequently in additional hospitals across the country[1].