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健世科技(09877.HK)LuX-Valve Plus臨床試驗結果於美國紐約瓣膜會發布
阿思達克 06-27 08:24
健世科技(09877.HK)公布,近期LuX-Valve Plus經血管三尖瓣介入置換系統的全球多中心臨床試驗(TRINITY)中大瓣環患者30天臨床隨訪結果於美國舉行的2025年紐約瓣膜會發布。 TRINITY是一項全球前瞻性、多中心、單臂臨床試驗,主要用於評估LuX-Valve Plus於重度三尖瓣反流及外科高危患者中應用的安全性及有效性。該項研究全分析集(FAS)共納入全球20家中心的149例患者,其中18家中心分布在法國、德國、英國、西班牙、丹麥等歐洲國家。 本次臨床研究結果顯示,大瓣環患者群體中器械成功率高達97%,小瓣環患者群體約為94%。有效性結果顯示,於三尖瓣反流等級改善方面,30天資料顯示95.7%的患者顯示無中度以上反流,其中,分別有95.4%的大瓣環患者和100%的小瓣環患者顯示無中度以上反流。 於生活品質改善方面,30天資料顯示患者堪薩斯市心肌病變問卷評分平均提升約14分,其中大瓣環患者平均提升約15分,小瓣環患者平均提升約12分。
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