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賽諾醫療(688108.SH):非順應性球囊導管申報國內醫療器械註冊獲得受理
格隆匯 04-19 17:52

格隆匯4月19日丨賽諾醫療(688108.SH)公佈,公司非順應性球囊擴張導管於近日向國家藥品監督管理局申報了醫療器械註冊申請。國家藥監局於2022年4月18日向公司簽發了《受理通知書》。

非順應性球囊擴張導管適用於為動脈粥樣硬化患者改善心肌灌注而針對自體冠狀動脈或搭橋狹窄部位所進行的球囊導管擴張。該產品還適用於球囊擴張支架(裸金屬和藥物洗脱支架)的遞送後擴張。

該產品是一種快速交換球囊擴張導管,其遠端附近有一個非順應性球囊。導管的遠端部分採用雙腔同軸設計,外腔用於球囊擴張,內腔允許使用直徑≤0.014”(0.36mm)的導絲。導管尖端為錐形,便於前推導管到達並通過狹窄或支架部位。

在公司一代球囊的基礎上,優化了內外管材質,推送性能更好。球囊頂端更加柔軟,不容易損傷血管;雙層球囊既為球囊提供了低順應性,高耐壓性能,同時也增加了球囊的柔順性,球囊更加柔軟。

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