健世科技-B(09877.HK)：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 the investigational device exemption (IDE) for its LuX-Valve Plus, marking a significant advancement in its global strategy and clinical registration process in the U.S. [1] Group 1: Product Development and Approval - The LuX-Valve Plus, a transcatheter tricuspid valve replacement system, 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 device's design advantages and its safety and efficacy in clinical applications [1] - The EFS has received approval from the Centers for Medicare & Medicaid Services (CMS), which will cover the necessary devices and related costs [1] Group 2: Future Plans and Market Strategy - 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 [2] - The goal is to commercialize LuX-Valve Plus in the U.S. and other global regions, benefiting a wide range of patients suffering from tricuspid regurgitation [2]