先健科技(01302.HK)LAmbre™左心耳封堵器 成功救治美國特殊心耳高齡患者
2021年4月,美國圖森市醫療中心,先健科技自主研發的LAmbre™左心耳封堵器系統成功救治了一位82歲的高齡特殊大心耳患者。該里程碑意義的手術,受到了美國圖森市當地電視台的採訪報道。
Donald Dixon先生患有持續性房顫,並因服用抗凝藥物導致了較為嚴重的體內出血。如果繼續服用抗凝藥,可能會加劇患者體內出血;倘若停止服用抗凝藥,房顫可能會導致血栓形成,並可能進一步發展成為腦卒中。
美國圖森市醫療中心結構性心臟病治療項目的負責人之一,Neil Gheewala醫生提議為Dixon先生實施左心耳封堵手術,以替代長期服用抗凝藥物。但由於患者的左心耳開口尺寸非常大,目前北美市場在售的左心耳封堵器無法提供適用於該患者心耳尺寸的型號。
先健科技自主研發的LAmbre™左心耳封堵器是目前全球市場已商業化的型號最齊全的左心耳封堵裝置,能夠為大心耳患者提供安全有效的手術治療方案。此前,先健科技自主研發的LAmbre™左心耳封堵器已在美國實現成功植入。Neil Gheewala醫生隨即與先健科技北美工作人員取得聯繫,希望採用LAmbre™左心耳封堵器為Dixon先生實施手術封堵。

(圖:先健科技自主研發的LAmbre™左心耳封堵器)
2020年12月底 ,先健科技的LAmbre™左心耳封堵器系統獲批由美國當地專業醫療機構研究者發起的臨牀使用,以評估採用該產品封堵大尺寸左心耳,以及封堵其它因左心耳解剖結構特殊而無法使用美國市場已商業化的產品進行手術封堵的患者的安全性和有效性。與此同時,Dixon先生內出血的情況開始出現惡化,使其不得不多次前往醫院進行輸血,彼時,LAmbre™在美國的臨牀項目尚未正式啟動患者植入。面對該緊急情況,Neil Gheewala醫生最終通過成功向FDA申請“Emergency Compassionate Use”(緊急同情使用),使患者得到了及時救治。
2021年4月,手術在美國圖森市醫療中心成功進行。美國斯坦福大學和匹茲堡大學的多位心內專家進行了遠程手術觀摩。手術採用先健科技型號為LT-LAA-3640的最大規格LAmbre™左心耳封堵器,手術用時不到一小時,非常成功,造影顯示患者左心耳封堵完全,無殘餘分流。
“這是一次極具里程碑意義的手術”,術後Neil Gheewala醫生表示:“手術的成功證明了先健科技LAmbre™左心耳封堵器系統的安全有效性,這讓我們有足夠的信心能夠使用它來幫助更多有需要的美國患者,為挽救更多具有類似情況的患者生命打開了新的治療思路。”
醫學無國界,創新無止境。先健科技LAmbre™左心耳封堵器系統傑出的產品設計、卓越的臨牀性能和全球佈局的知識產權將進一步促進其在北美乃至全球市場的縱深發展,讓中國創新,先健智慧,“貼心”陪伴,惠及全球。
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