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啟明醫療-B(02500.HK):可擴張生物幹瓣VENUS-NEO完成首例臨牀應用
格隆匯 04-12 18:56

格隆匯4月12日丨啟明醫療-B(02500.HK)公吿,公司自主研發的新一代可擴張生物幹瓣Venus-Neo,已在華中科技大學同濟醫學院附屬協和醫院成功完成首例應用於人體(First-in-Man,FIM)的臨牀試驗。

作為公司首款外科生物瓣,Venus-Neo採用環上瓣設計,以牛心包組織作為瓣葉,通過優化瓣膜設計和獨特的抗鈣化幹化處理技術(Venus-Endura),可置於無液體環境下保存,且不含醛殘留,在提升安全性的同時,便於臨牀使用和儲藏運輸。

隨着中國老齡化加重,主動脈瓣疾病已經成為最常見的心臟瓣膜病一,外科主動脈瓣置換術(SAVR)是目前治療主動脈瓣狹窄和主動脈瓣反流最為成熟的方式,長期的循證醫學證據充分。然而,生物瓣衰敗後再次手術帶來的高風險也不容忽視。瓣中瓣手術已被逐步應用於外科生物瓣膜衰敗的治療,而Venus-Neo的瓣膜支架採用可擴張設計,為未來需要接受"瓣中瓣"治療的患者提供更優選擇。

這是繼Venus-Vitae和Venus-PowerX後,公司又一款進入臨牀研究的新一代特製幹瓣產品,標誌着啟明醫療在提升生物瓣膜使用壽命的同時,實現主動脈瓣膜疾病解決方案的全佈局,對於鞏固公司在中國心臟瓣膜病治療領域的領導者地位具有里程碑意義。董事會期待Venus-Neo早日完成臨牀研究,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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