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歸創通橋-B(02190.HK):ZENFLEX外周血管支架系統完成歐盟地區上市後臨牀試驗全部患者入組
格隆匯 12-20 19:23

格隆匯12月20日丨歸創通橋-B(02190.HK)公吿,由公司自主研發的ZENFLEX外周血管支架系統完成德國多中心臨牀試驗的全部100名患者入組。該臨牀試驗是一項前瞻性、多中心、單臂設計的評價ZENFLEX外周血管支架系統用於輔助血管成形術治療外周動脈疾病的有效性及安全性研究,由世界著名血管介入專家、德國萊比錫大學附屬醫院Dierk Scheinert教授擔任協調研究者,歐洲五家醫院的血管介入臨牀專家共同參與。這是ZENFLEX外周血管支架系統在歐盟開展的上市後臨牀跟蹤試驗,對於印證該產品在海外的臨牀價值,獲得歐盟MDR認證並持續為海外患者服務具有重要意義。

ZENFLEX外周血管支架系統主要用於治療外周動脈疾病(Peripheral ArterialDisease,PAD)。其擁有獨特的開環螺旋結構和微網孔設計,具備優秀的柔順性和徑向支撐力,更好地貼合血管壁。同時,ZENFLEX外周血管支架系統還擁有可控的輸送系統,能夠精準、快速、便捷實現支架釋放。該產品自2017年在歐盟上市以來,憑藉創新的產品設計和高質量的產品品質,獲得了當地醫生的認可和歡迎。截止本公吿發布之日,公司已有8款產品獲得表明在歐洲經濟區內所售產品符合健康、安全及環保標準的認證標誌,1款產品獲批在巴西上市。

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