歸創通橋-B(02190.HK)：國家藥監局批准顱內動脈瘤栓塞彈簧圈在中國上市
格隆匯9月27日丨歸創通橋-B(02190.HK)宣佈，公司自主研發的顱內動脈瘤栓塞彈簧圈已獲得中國國家藥品監督管理局("國家藥監局")的上市批准，用於治療顱內出血性卒中("國家藥監局的上市批准")。
顱內動脈瘤栓塞彈簧圈是第三類植入式醫療器械。顱內動脈瘤栓塞彈簧圈是一套用於血管內彈簧圈栓塞術(一種使用導管接觸腦部的動脈瘤，置換彈簧圈以阻止血液流入動脈瘤，從而降低動脈瘤破裂風險的微創技術)的彈簧圈。
我們已於中國完成一項多中心、單盲非劣效性試驗，以評估顱內動脈瘤栓塞彈簧圈的有效性和安全性。試驗流程於11家中心完成，合共招募256名受試者，其中長海醫院(一家專注於神經血管疾病的三甲醫院)為領先的主要研究機構。綜上所述，與一家國際醫療器械公司所開發的一款市場主導商業化顱內動脈瘤栓塞彈簧圈(同類產品)相比，全面試驗結果顯示出非劣效性。
與市場上其他主要彈簧圈相比，我們的顱內動脈瘤栓塞彈簧圈更加輕柔且對動脈瘤壁的壓力最小，因而可降低引起動脈瘤破裂或其他損傷的風險，且通過利用我們的獨特機械分離技術，其亦更容易從推送裝置中解脱。與電解可解脱彈簧圈相比，此分離技術的解脱更快，不需要其他特殊儀器完成解脱。我們亦提供更多不同長度和直徑的彈簧圈選擇，包括六種不同的1mm直徑彈簧圈。
國家藥監局的上市批准象徵集團治療顱內出血性卒中的產品以及集團神經血管產品組合的重大進展，標誌着集團在神經血管介入醫療器械行業的成就，亦證明集團的發展能力，反映出集團強大的內部研發能力。截至目前，集團共有12款產品在中國獲國家藥監局的上市批准，8款產品在中國以外獲得CE標誌，就已獲批准的產品總數而言，集團是中國神經和外周血管介入醫療器械市場的領導者。
取得國家藥監局的上市批准後，我們擬於中國商業化顱內動脈瘤栓塞彈簧圈，並考慮於中國市場之外開發該產品。我們計劃升級顱內動脈瘤栓塞彈簧圈以提升彈簧圈的多種性能，例如通過改善選料和加工技術提高其形狀保持能力。我們的顱內動脈瘤栓塞彈簧圈亦將與血流導向裝置結合使用，以提高顱內動脈瘤的手術效率。
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