啟明醫療-B(02500.HK):球擴乾瓣TAVR產品VENUS VITAE成功完成全球首兩例臨牀應用
格隆匯12月20日丨啟明醫療-B(02500.HK)發佈公吿,公司自主研發的新一代經導管主動脈瓣置換(TAVR)系統Venus Vitae,於12月16日成功進行全球首兩例應用於人體(First-in-Man,FIM)的臨牀試驗,由阿根廷科達特斯InstitutoDeCardiologia醫院的巴卡羅教授團隊主導完成。
根據披露,主動脈瓣狹窄是最常見的心臟瓣膜病之一,容易導致冠狀動脈缺血、腦缺血等,從而引發心絞痛或者其他嚴重的併發症,目前已經成為全球因瓣膜病導致死亡的主要病因。因全球老齡化人口不斷增長,主動脈瓣狹窄患病率不斷上升。TAVR市場方興未艾,仍存在巨大的、未被滿足的患者需求。
Venus Vitae作為公司最新一代球擴乾瓣TAVR系統,在提高瓣膜壽命、縮短手術時長等方面均有顯着優勢。Venus Vitae採用環上瓣設計,以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,極大地方便臨牀使用和瓣膜儲藏及運輸;同時Venus Vitae具有自主研發的線鎖專利設計,保證在輸送和釋放過程中精準定位,輸送系統直徑較小,擁有較強的過弓能力。
Venus Vitae首次FIM成功完成兩例植入,為後續在全球的臨牀試驗奠定良好基礎。董事會期待Venus Vitae早日上市,實現對現有經導管瓣膜置換術治療解決方案的有力提升,為全球心臟瓣膜病患者提供高品質的術後生活。
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