先健科技(01302.HK)：Futhrough™主動脈覆膜支架破膜系統進入創新醫療器械特別審批程序
格隆匯4月22日丨先健科技(01302.HK)宣佈，於2020年4月17日，公司獲得國家藥監局的正式批准，確認Futhrough™主動脈覆膜支架破膜系統(又名腔內穿刺系統)進入國家藥監局創新醫療器械特別審批程序，成為公司第十個進入該程序的創新產品。
Futhrough™主動脈覆膜支架破膜系統是一款原位開窗器械，用於行原位開窗術對主動脈分支血管重建時，對主動脈覆膜支架進行破膜(開窗)。產品包含導管和穿刺針。穿刺針由針頭、柔性金屬針管和手柄組成，穿刺針頭連接柔性的針管，可以順應彎曲的主動脈弓分支血管，同時提供導絲通道，便於穿刺成功後導絲進入；穿刺手柄可以調節穿刺距離，避免誤傷組織。該產品具有易操作性、較強的穿刺有效性，優秀的解剖適應性以及相對更廣泛的適應症等特點。
原位開窗術是指通過特製的開窗器械，在需要重建的弓部分支血管開口處刺破主動脈覆膜支架，並通過球囊擴張穿刺點形成可供血液流通的窗口，隨後植入分支支架保證窗口的通暢，完成弓部分支血管重建。該技術具有不改變生理血流方向、最小化內漏風險、定位難度相對較小等優勢，是對累及主動脈弓部病變的有效腔內介入治療方式之一。
在行原位開窗術時，通過該產品與公司在研的主動脈弓支架系統(即，AnkuraTMPlus主動脈弓主體支架系統和CSkirt™主動脈弓分支支架系統)的聯合使用，能夠有效解決主動脈弓部病變因其解剖形態複雜，錨定區不足，保留分支血管困難等問題，共同為累及主動脈弓部病變的患者帶來更安全、有效的腔內介入解決方案。
董事會相信，進入該程序有利於公司優化公司產品的註冊路徑，進而加快其在中國的上市進程，並有利於促進公司在主動脈弓支架系統上的研究和臨牀工作，從而令廣大累及主動脈弓部病變的患者能夠更早的受益。同時，還將進一步豐富並完善集團在腔內介入治療器械上的創新產品佈局，有力推動集團的長期穩健發展。
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