先健科技(01302.HK)：主動脈覆膜支架系統獲得中國國家藥品監督管理局的正式註冊批準
格隆匯2月12日丨先健科技(01302.HK)公告，於2025年2月8日，由中國醫學科學院阜外醫院舒暢教授領銜，與集團共同研發的主動脈覆膜支架系統("該產品")獲中國國家藥品監督管理局正式註冊批準。該產品爲國家藥品監督管理局批準的首款明確適用於煙囪技術的主動脈覆膜支架系統，爲累及主動脈弓部病變的患者提供了一種操作簡便、安全有效、解剖適應廣泛的治療新選擇。
該產品由AnkuraTMPro主動脈主體覆膜支架系統和LonguetteTM主動脈分支覆膜支架系統組成。AnkuraTMPro採用ePTFE覆膜，並提供0-10多種錐度，可滿足不同的臨牀需求。LonguetteTM裙邊支架採用帶外層裙邊的雙層結構設計，外層裙邊可在支架釋放後有效填補分支支架與主動脈支架的間隙，預期可以防止和減少內漏發生，降低併發症風險。三年隨訪結果顯示，內漏發生率僅3.36%，遠低於傳統煙囪技術(10.7%~16.4%)。內層高密度鎳鈦合金骨架，近端加強段提供強徑向支撐力，防止被主動脈支架壓閉，確保分支血管遠期通暢。術後一年隨訪分支血管通暢率97.87%，高於傳統煙囪術式分支血管通暢率(93%)。該產品操作便捷，安全高效，即刻技術成功率99.33%，術後一年夾層治療成功率95.77%。
該產品擁有自主知識產權和多項國際專利，預期可爲治療累及主動脈弓部病變的患者提供一套完整、安全、有效的腔內修復解決方案。該解決方案完全採用介入方式，預計優勢爲造成的創傷更小，操作更簡單。
該產品是公司主動脈弓部分支重建整體解決方案中首款獲批的產品。隨着商業化進程的持續推進，公司將爲主動脈弓腔內重建提供更靈活、完整、安全有效、操作簡便的整體解決方案，並攜手業內專家推進更多臨牀急需器械產品的研發和上市，驅動集團於醫療器械領域的發展，造福廣大患者。
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