健世科技-B（09877）7月16日自愿公告称，公司自主研发的经导管三尖瓣置换系统LuX-Valve Plus已在美国食品及药品监督管理局（FDA）批准的关键性注册临床试验（Pivotal Trial）中完成首批受试者植入。该进展是在产品取得EU MDR CE认证后，公司全球化战略的又一重要里程碑。
此次临床试验为前瞻性、全球多中心研究，覆盖美国、加拿大及多个欧洲国家，并将与爱德华生命科学EVOQUE系统进行头对头随机对照，以主要评估LuX-Valve Plus在重度三尖瓣反流患者中的安全性及有效性。
公司表示，基于LuX-Valve Plus的设计优势及临床表现，该试验获得全球多中心积极参与，将持续加速推进试验进程。
健世科技-B提醒投资者，根据香港联合交易所有限公司证券上市规则第18A.05条，概不保证LuX-Valve Plus最终能成功推向市场及/或商业化。公司股东及潜在投资者在买卖公司股份时应审慎行事。
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