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賽諾醫療(688108.SH):產品HT Supreme™藥物洗脱支架系統獲得歐盟MDR認證
格隆匯 11-09 16:55

格隆匯11月9日丨賽諾醫療(688108.SH)公佈,公司於2022年05月向歐盟公吿機構遞交了公司HT Supreme™藥物洗脱支架系統按照歐盟醫療器械法規Medical Devices Regulation(EU)2017/745(簡稱“MDR”)註冊認證的申報資料。公司於近日收到歐盟公吿機構通知,公司HT Supreme™藥物洗脱支架系統獲得按照歐盟MDR法規簽發的歐盟MDR認證。

HT Supreme™藥物塗層冠狀動脈支架系統是一種藥械組合產品,由藥物塗層的可擴張鈷鉻(CoCr)合金冠狀動脈支架和球囊輸送系統組成。本支架底部塗覆不可腐蝕的聚合物層,表面塗覆供藥物釋放的生物可降解聚合物層。藥物釋放的生物可降解聚合物層由sirolimus 和生物可降解聚合物的混合物組成。使用快速交換球囊可擴張輸送系統來輸送支架。產品保存期限為自滅菌之日起12個月。

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