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賽諾醫療(688108.SH):顱內藥物洗脱支架系統申報國內醫療器械註冊獲得受理
格隆匯 12-24 17:01

格隆匯 12 月 24日丨賽諾醫療(688108.SH)公佈,公司顱內藥物洗脱支架系統於近日向國家藥品監督管理局(“國家藥監局”)報了醫療器械註冊申請國家藥監局20201223向公司《受理通知書》。

預期用途:顱內藥物洗脱支架系統用於顱內動脈病變,對狹窄和梗阻的管腔具有支撐和開通作用,改善顱內動脈管腔直徑,改善腦組織缺血;同時能有效預防支架內的再狹窄。參考血管直徑為2.25-4.0mm,適用的病變長度小於等於20mm

公司的顱內藥物洗脱支架系統是全球首個專用於顱內動脈狹窄治療的藥物洗脱支,適用於症狀性顱內動脈粥樣硬化狹窄的治療。

產品通過獨特的藥物塗層設計使得藥物支架具有最佳的藥物釋放動力學,藥物在血管壁中濃度同平滑肌細胞增殖時程相匹配,精準抑制平滑肌細胞過度增生,在有效降低再狹窄率的同時最大程度降低藥物對血管內皮細胞的抑制作用,使得血管內皮可在內皮修復窗口期(二至三個月)內實現快速覆蓋和修復。

該產品針對顱內血管解剖結構,採用匹配顱內血管的開環“s-link”連接設計,在保持有效血管支撐力的要求下,優化產品操控性能,提升支架柔順性及血管貼合性使產品更適合在顱內的迂曲血管進行臨牀使用相比於裸支架,顱內藥物洗脱支架系統將降低血管再狹窄率,從而降低再次卒中復發風險,為患者提供更安全有效的治療手段。

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