Core Viewpoint - The company has received FDA approval for the pivotal trial of its self-developed tricuspid valve intervention replacement system, LuX-Valve Plus, marking a significant advancement in its global strategy and clinical registration process in the U.S. [1] Group 1: Product Development - LuX-Valve Plus has shown excellent performance in clinical trials conducted in China and Europe [1] - The early feasibility study (EFS) data in the U.S. further validates the design advantages and clinical safety and efficacy of 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 of the pivotal trial and subsequent key registration clinical trials [1] Group 3: Future Plans - The company will actively advance the enrollment for the pivotal 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]
健世科技-B：LuX-Valve Plus关键性注册临床试验获得FDA批准