健世科技-B(09877)：LuX-Valve Plus关键性注册临床试验获得FDA批准

Core Viewpoint - The company has received FDA approval for its LuX-Valve Plus device, marking a significant advancement in its global strategy and clinical trial process in the U.S. [1] Group 1: Product Development - The LuX-Valve Plus is a self-developed transcatheter tricuspid valve replacement system that has shown excellent performance in clinical trials conducted in China and Europe [1] - The early feasibility study (EFS) in the U.S. has further validated the design advantages and clinical safety and efficacy of the LuX-Valve Plus [1] Group 2: Regulatory Approvals - The early feasibility study has been approved by the Centers for Medicare & Medicaid Services (CMS), with the necessary devices and related costs covered by CMS [1] - The recent progress lays a solid foundation for the approval and subsequent conduct of the pivotal clinical trial [1] Group 3: Future Plans - The company will actively advance the enrollment for the pivotal clinical trial of LuX-Valve Plus, aiming to obtain FDA market approval as soon as possible [1] - The goal is to commercialize LuX-Valve Plus in the U.S. and other global regions, benefiting a wide range of patients with tricuspid regurgitation [1]