賽諾醫療(688108.SH):新一類藥物洗脱支架系統申報美國上市前批准獲得FDA受理
格隆匯12月8日丨賽諾醫療(688108.SH)公佈,公司於2021年12月向美國食品藥品監督管理局(簡稱“FDA”)遞交了公司新一類癒合導向藥物洗脱支架系統(商品名稱:HTSupreme)上市前批准(簡稱“PMA”)的最終申報資料,並於近日收到FDA的《受理信》,公司新一類藥物洗脱支架系統獲得FDA正式受理,並進入上市前批准(PMA)最終審評流程。
產品名稱:冠脈藥物洗脱支架系統;預期用途:該冠脈藥物洗脱支架系統適用於改善原發冠狀動脈病變而導致的症狀性缺血性心臟病患者的冠狀管腔直徑,病變長度應不超過31mm,參考血管直徑為2.25-4.00mm。
該藥物洗脱支架系統於2019年12月19日取得歐盟CE認證,並於2020年12月31日取得國家藥品監督管理局頒發的《醫療器械註冊證》(具體內容詳見公司在上海證券交易所網站上披露的相關公吿)。目前,該產品在歐洲及中國均已開始商業化植入,在歐洲和中國的上市後臨牀研究也均按計劃進行中。
基於公司在美國、日本、加拿大、歐洲等地發起的全球多中心、隨機對照研究(PIONEER III)的主要終點隨訪結果,公司於近日向FDA提交了該產品美國上市前批准(PMA)的最終申報資料。截至本公吿披露日,公司已完成該產品美國上市前批准(PMA)全部五個模塊的註冊申報。
上述申報資料提交後,該產品尚需經過 FDA資料完整性、實質性審查、批准前現場審核(PAI)和臨牀試驗監查(BIMO)等一系列的評審過程,預計將在2022年年獲批上市。
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