賽諾醫療(688108.SH):新一代藥物洗脱支架系統申報境內醫療器械註冊獲受理
格隆匯 6 月 29日丨賽諾醫療(688108.SH)公佈,公司新一代藥物洗脱支架系統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2020年6月28日簽發了《受理通知書》。
產品名稱:藥物洗脱支架系統,預期用途:本產品適用於冠狀動脈血管成形術。藥物洗脱支架系統參考血管直徑為2.5-4.0mm,適用的病變長度小於等於35mm,用於改善局部缺血型心臟病患者的血管狹窄症狀。PTCA術中的急性閉塞或瀕臨閉塞;PTCA結果不滿意,殘留狹窄明顯的病變;PTCA術後冠狀動脈再狹窄病變。
此次申請註冊的藥物洗脱支架系統是公司在第一代藥物支架基礎上開發的新一代藥物洗脱支架,採用了已申請國際專利的支架設計、eG 電子接枝塗層技術、可生物降解聚合物和西羅莫司載體藥物。
該藥物洗脱支架於 2012 年底立項,目前已在歐洲、美國、日本、中國等地區開展全球性臨牀研究。其中,歐洲 PIONEER I研究已順利完成並於2019年12月19日取得歐盟CE認證,成為該產品在全球獲得的首個批准證書;基於中國PIONEER II研究申報的境內醫療器械註冊申請已獲得國家藥監局正式受理;美國、日本PIONEER III研究已於2019年7月完成全部病人入組,目前處於臨牀隨訪階段。
截至目前,公司尚未在歐盟及其他地區正式銷售該產品。該產品在境內的審批進程僅處於申請受理階段,對公司目前的經營不構成直接影響。
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