JenaValve's transcatheter aortic valve replacement device (TAVR-AR) has received pre-market approval from the US Food and Drug Administration (FDA), making it the first device of its kind to treat the heart condition. The designation distinguishes the first TAVR device to be granted a dedicated indication in the US for treating eligible severe AR patients deemed to be at high or greater risk for surgical aorticism valve replacement (SAVR). This approval was supported by data from the ALIGN-AR pivotal trial (NCT04415047), and Investigational Device Exemption (IDE) study that assessed the safety and efficacy of the Trilogy THV System in high-surgical-risk patients with symptomatic, severe AR. JenaValves plans to immediately commence launch activity for Trilogy with participating clinical study sites, followed by additional hospitals across the US. The GlobalData market model suggests that the addition of AR could potentially push the market's CAGR into the double-digit range.