賽諾醫療(688108.SH):新一代藥物洗脱支架系統取得國內醫療器械註冊證
格隆匯1月8日丨賽諾醫療(688108.SH)公佈,近日,公司收到國家藥監局頒發的關於公司新一代Supreme HT(Healing Targeted)“藥物洗脱支架”的醫療器械註冊證。
藥物洗脱支架系統由藥物塗層支架和快速交換球囊導管輸送系統組成。藥物塗層支架以L605鈷鉻合金支架為基體,表面塗覆底部塗層和含藥高分子塗層。底部塗層材料為聚甲基丙烯丁酯(PBuMA),該塗層不可降解;藥物塗層由雷帕黴素藥物和聚乳酸-羥基乙酸(PLGA)組成,為可降解塗層。支架藥物劑量密度為1.20μg/mm2;載藥量59μg-285μg。輸送系統由TIP頭、球囊、Marker、球囊內管、球囊外管和手柄組成。產品經過電子束滅菌,一次性使用。貨架有效期1年。
該產品適用於參考血管直徑為2.5-4.0mm,病變長度≤35mm,用於改善局部缺血型心臟病患者的血管狹窄症狀。
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