先健科技(01302.HK)IBS Angel™鐵基可吸收支架系統成功完成美國首例植入
美國時間2022年3月24日，由先健科技(01302.HK)控股子公司元心科技(深圳)有限公司自主研發的創新產品鐵基可吸收支架系統(“IBS Angel™”)於美國西艾利斯市威斯康辛州兒童醫院成功完成其於美國的首例植入。該產品通過美國FDA “Compassionate Use”(同情使用)批准，是先健科技鐵基可吸收材料平台下第二款在美國實現成功植入的產品。
接受IBS Angel™植入的患者僅7月齡，患有法洛四聯症並曾接受外科修復手術治療。患兒於不久前發生右室流出道梗阻，需及時進行手術干預。考慮到患兒的病史與年齡，再次行外科手術會對患兒造成巨大的手術創傷和極高的手術風險，因此支架植入術被認為是最適合該患兒的治療方式。但北美市場目前尚無針對右室流出道設計的專用支架。同時，對於低齡患兒，永久支架植入後會限制患兒右心室的正常生長，並對其後期潛在的手術干預帶來更大難度。
IBS Angel™是專為兒童肺血管設計開發的可吸收支架，用於改善需要支架治療的患兒的肺血管管腔直徑，是全球首款以鐵基為主體材料的全降解肺血管支架。IBS Angel™的各項力學性能、臨牀操控性能均與市面上主流的鈷鉻合金永久支架相當，支架直徑可覆蓋全部肺血管直徑範圍。支架由高強度和高塑性的高純滲氮鐵管制成，支架壁薄且支撐力強，其最小可兼容4F鞘管(內徑約1.35毫米)，可以輕鬆進入新生兒和嬰幼兒細小的血管。IBS Angel™植入後，在血管重塑期內能夠保持對血管的有效支撐，防止血管彈性回縮，隨後支架開始逐步降解吸收，並將解除對血管的徑向束縛，不影響血管的正常生長，從而為新生兒及低齡嬰幼兒患者帶來理想的疾病解決方案。
在充分了解並評估確認IBS Angel™針對患兒的臨牀優勢後，主治醫生向美國FDA申請了“Compassionate Use”(同情使用)，並於2022年3月11日獲得正式批准。即刻起程，穿越山海。代表着填補目前相關領域空白的鐵基可吸收支架，在最快時間內為美國低齡患兒帶去了生命的希望。
作為全球唯一適用於兒童的鐵基可吸收支架，IBS Angel™獲批美國FDA “Compassionate Use”(同情使用)並實現成功植入，體現了北美核心市場臨牀專家對該創新產品技術優勢的充分認可。“醫學無國界”，中國創新醫療技術再次為解決臨牀空白帶來積極意義。目前，IBS Angel™已獲得馬來西亞註冊證，歐盟CE註冊和中國註冊臨牀入組均在穩步推進，其有望成為歐盟和國內首款商業化的鐵基可吸收支架，為廣大患者帶來前所未有的治療新選擇。
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