JENSCARE-B (09877) has announced that its self-developed transcatheter tricuspid valve replacement system, LuX-Valve Plus, has officially received unconditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for its pivotal registration clinical trial. This marks a significant breakthrough in the product's registration process in the United States and the group's global strategic advancement. LuX-Valve Plus has demonstrated excellent performance in registration clinical trials conducted in China, Europe, and other regions. Clinical data from the U.S. Early Feasibility Study (EFS) further validated the device's design advantages, as well as its clinical safety and efficacy. The Early Feasibility Study for LuX-Valve Plus has also received approval from the U.S. Centers for Medicare & Medicaid Services (CMS), with the required device and associated costs covered by CMS Medicare. These developments lay a solid foundation for the approval of the current pivotal registration clinical trial and the subsequent execution of the trial. The company will now actively advance patient enrollment for the LuX-Valve Plus pivotal registration clinical trial, striving to obtain FDA marketing approval for the product as soon as possible and promote its commercialization in the United States and other global markets, ultimately benefiting a broad population of patients with tricuspid regurgitation worldwide.