賽諾醫療(688108.SH):藥物洗脱支架系統獲得國內醫療器械註冊證
格隆匯9月26日丨賽諾醫療(688108.SH)公佈,公司收到國家藥監局頒發的關於公司“藥物洗脱支架系統”的《醫療器械註冊證》。
結構及組成: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酸丁酯(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-324μg。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18個月。
適用範圍:該產品適用於參考血管直徑為2.25-4.00mm,適用的病變長度小於等於40mm,用於改善局部缺血型心臟病患者的血管狹窄症狀。
公司此次獲批的冠脈“藥物洗脱支架系統”,主要用於改善局部缺血型心臟病患者的血管狹窄症狀。該產品以提高患者創傷癒合速度為導向,旨在加速植入支架後血管內皮的恢復,通過新型的藥物釋放曲線實現抗增殖藥物的精準釋放和聚合物的降解,最小程度地影響內皮自然生長,從而減少傳統藥物塗層支架(DES)導致的遠期追趕效應及由此引發的不良事件發生率,提高產品的長期安全性。該產品於2022年9月20日獲得國家藥品監督管理局頒發的《醫療器械註冊證》。
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