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賽諾醫療(688108.SH)新一代冠脈藥物洗脱支架獲得CE認證證書
格隆匯 12-22 15:16

格隆匯12月22日丨賽諾醫療(688108.SH)發佈,2019年12月19日,公司獲得國際認證機構DEKRA Certification B.V.頒發的關於公司新一代冠脈藥物洗脱支架的CE認證證書。

公司新一代冠脈藥物洗脱支架產品已在歐洲、美國、日本、中國等地區開展全球性臨牀研究。其中,歐洲PIONEERI順利完成並於2019年12月19日獲得CE認證,成為該產品在全球獲得的首個批准證書;中國PIONEERII研究已完成入組及隨訪,目前處於申報準備階段;美國、日本PIONEERIII研究已於2019年7月完成全部1632例病人入組,目前處於臨牀隨訪階段。

公司稱,公司新一代冠脈藥物洗脱支架取得CE認證證書表明該產品符合歐盟相關要求,已經具備歐盟市場的准入條件,可以在歐盟及相關海外市場銷售,有助於擴充公司海外銷售產品品類並加快公司開拓國際市場的步伐。

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