開立醫療(300633.SZ)申報醫療器械註冊獲得批准 涉及電子支氣管內窺鏡
格隆匯5月21日丨開立醫療(300633.SZ)公佈，公司的一種醫療器械產品已獲國家藥品監督管理局批准，於近日取得中華人民共和國醫療器械註冊證，證書批准日期為：2020年5月8日，有效期至：2025年5月7日，註冊證編號：國械注準20203060467。產品的基本信息如下：
該種醫療器械產品目前已完成第三類醫療器械註冊證核發，並取得了《中華人民共和國醫療器械註冊證》。
全球範圍內，肺癌的發病率、死亡率都極高且呈上升趨勢。2018年全球統計數據顯示，男性肺癌發病率及死亡率均佔惡性腫瘤的第一位，在女性人羣中，肺癌的發病率列惡性腫瘤的第3位。我國2015年統計顯示，肺癌分別為男性和女性人羣惡性腫瘤發病率的第一位和第二位，而死亡率均居首位。支氣管鏡是早期準確識別和診斷肺癌的關鍵技術，是提高肺癌患者生存率的關鍵。
纖維支氣管鏡由於清晰度不足，日漸被電子支氣管鏡所替代。電子支氣管內窺鏡是一種經口或鼻置入患者下呼吸道，用於做肺葉、段及亞段支氣管病變的觀察、活檢採樣、細菌學和細胞學檢查，配合圖像處理器使用，通過視頻顯示器為氣管、支氣管的觀察、診斷和治療提供圖像的醫療器械。
電子支氣管鏡在新冠病毒檢測中發揮了重要作用。新型冠狀病毒檢測的金標準為核酸檢測，但核酸檢測的準確性嚴重依賴於檢測樣本的取樣方式和取樣位置。已有多起病例表明上呼吸道咽拭子檢測新冠病毒的假陰性率較高，易造成病患漏診。基於新冠病毒主要入侵下呼吸道的特點，多家醫院依靠支氣管鏡下肺泡灌洗取樣，發現了咽拭子檢測未曾發現的新冠病毒。國家衞健委發佈的新冠肺炎檢測指南也明確指出：“每個病例必須採集急性期呼吸道標本(包括上呼吸道標本和下呼吸道標本)；重症病例優先採集下呼吸道標本(如支氣管或肺泡灌洗液等)”。另外，危重症病患的肺部易被病毒導致的果凍狀分泌物堵塞，導致病患缺氧窒息。支氣管鏡吸痰可有效清除氣道內的分泌物，解除通氣功能障礙。
公告中提及獲得註冊證的產品為國產首台分辨率達高清的電子支氣管鏡，操控性良好，可以很好的滿足臨牀的使用，完成支氣管鏡下診斷及治療工作。
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