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開立醫療(300633.SZ):電子下消化道內窺鏡取得醫療器械註冊證
格隆匯 02-07 16:26

格隆匯2月7日丨開立醫療(300633.SZ)公佈,公司的一種醫療器械產品已獲廣東省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。

產品名稱:電子下消化道內窺鏡;臨牀用途:與公司生產的醫用內窺鏡圖像處理器(型號:HD-550、HD-550Exp、HD-550Pro、HD-550S、HD-510、HD-500Plus)配合使用,用於通過視頻顯示器提供影像供下消化道(包括肛門、直腸、結腸、回盲部)觀察、診斷和治療

結腸鏡是臨牀診療結腸疾病最直觀、最準確的方法。但其屬侵入性診療項目,在檢查過程中,患者會產生腹痛、腹脹及應激反應如心率加快、血壓升高等,許多患者因為恐懼檢查過程中的痛苦而放棄檢查貽誤病情。為了減輕患者病痛,緩解患者緊張情緒,尤其對於一些特殊人羣,如老人、婦女、危重症患者等,公司推出超細結腸鏡EC-P550S系列。

與普通結腸鏡12.5mm的外徑比較,EC-P550S的外徑僅有9.5mm,接受超細結腸鏡檢查的患者,盲腸插入成功率、全結腸檢查的完成率一致,但腹痛、腹脹等不適反應大幅減輕。對於腸腔良性狹窄或惡性腫瘤所致的狹窄的患者,超細結腸鏡具有明顯優勢。對於無條件開展麻醉狀態下無痛結腸鏡檢查的醫院,可選擇應用超細結腸鏡檢查,以減輕患者痛苦及經濟負擔。

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