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啟明醫療-B(02500.HK):國際首款全釋放可回收乾瓣產品Venus-PowerX成功完成全球首例臨牀應用
格隆匯 12-22 20:09

格隆匯12月22日丨啟明醫療-B(02500.HK)公吿,公司自主研發的新一代經導管主動脈瓣置換術(TAVR)系統、全球首款全釋放可回收乾瓣產品Venus-PowerX,已於12月21日在四川大學華西醫院成功完成首例應用於人體(First-in-Man,FIM)的臨牀試驗,該院心內科主任陳茂教授擔任主要研究者(PI)。

主動脈瓣狹窄是心臟瓣膜病中最常見的疾病之一。隨着全球人口的老齡化,老年性心臟瓣膜病越來越受到重視,瓣膜病已成為繼冠心病,高血壓後的主要心血管疾病。研究表明,在75歲以上的人羣中,心臟瓣膜病的發病率為13.2%。在80-89歲的人羣中,主動脈瓣狹窄發病率為9.8%。

儘管TAVR在全球日漸成為主流的瓣膜疾病治療方式,但已上市TAVR產品的材料、特性等方面仍有較大的提升空間,未能充分滿足患者治療需求。Venus-PowerX作為本公司新一代全釋放可回收乾瓣TAVR系統,與全球已上市產品相比,在提高瓣膜壽命、增加手術安全性、提升操作性能等方面均有顯著提升。

Venus-PowerX運用先進的抗鈣化處理工藝提高瓣膜耐久性,特製乾化的瓣膜可進行預裝,且不含醛殘留,在提升安全性的同時,便於臨牀使用和瓣膜儲藏運輸。同時,Venus-PowerX具有獨特的線控設計,在瓣膜100%完全釋放後,仍可進行回收,更具安全性。此外,該產品的輸送系統採用新的鞘管設計,優化了柔順性及過弓性。

自膨乾瓣產品Venus-PowerX和球擴乾瓣產品VenusVitae相繼開啟全球臨牀試驗,標誌着公司創新乾瓣技術平台臻於成熟,亦是公司全球化發展的一大里程碑。董事會期待Venus-PowerX早日完成國內和國際多中心臨牀研究,並將繼續發揮技術優勢,佈局新一代產品,持續創新迭代,造福全球心臟瓣膜病患者。

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