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先健科技(01302.HK):鎳鈦合金動脈導管未閉封堵器進入創新醫療器械特別審查程序
格隆匯 08-22 08:04

格隆匯8月22日丨先健科技(01302.HK)發佈公告,2025年8月20日,公司收到國家藥品監督管理局(“國家藥品監督管理局”)的正式書面通知,確認鎳鈦合金動脈導管未閉封堵器“該產品”)進入國家藥品監督管理局創新醫療器械特別審查程序(“該程序”)。該產品爲公司第十六個進入國家藥品監督管理局該程序的產品。

動脈導管未閉(PDA)是臨牀上最常見的先天性心臟病之一,約佔所有先天性心臟病發病率的12%至15%。如果未能及時治療,可能導致肺動脈高壓、心力衰竭等嚴重併發症。經導管PDA封堵術因其微創、安全、恢復快等優勢,已逐漸成爲符合適應症患者的首選治療方案。然而,由於PDA存在不同結構和尺寸,且患者的血管條件各異,對封堵器械的適應性提出了更高挑戰,使臨牀更需要兼顧多種情況的創新器械。

該產品適用於先天性心臟PDA的介入治療,是國產首創可實現“靜脈順行”與“動脈逆行”雙向路徑釋放的全鎳鈦金屬主體結構PDA封堵器。該產品由鎳鈦合金絲整體編織成型,採用自膨式非對稱雙盤結構設計。其左右盤均可與輸送鋼纜連接,可根據患者情況靈活選擇“順行”或“逆行”兩種植入路徑。與傳統的順行路徑相比,逆行入路操作更爲簡便,不僅能夠縮短手術時間,也爲存在靜脈系統禁忌的患者提供了更佳的治療選擇,從而讓醫生在面對不同的PDA病症挑戰時,擁有更靈活的解決方案。

集團擁有該產品的自主知識產權。目前,該產品在中國的註冊臨牀試驗正穩步推進,公司預計後續將有更加豐富的循證醫學證據進一步證實該產品的安全性和有效性。董事會相信,該產品進入該程序將縮短該產品的註冊流程,進而加快其上市進程。預期該產品的上市將會令PDA患者受益,同時將擴充公司產品種類,從而推動集團於醫療器械領域的發展。

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