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心通醫療-B(02160.HK):Anchor Man®左心耳封堵器系統及其導引系統CE標誌批準
格隆匯 02-21 22:49

心通醫療-B(02160.HK)公告,董事會欣然宣佈,Anchor Man®左心耳封堵器系統及其導引系統已獲得CE標誌(表明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)批準。

Anchor Man®左心耳封堵器系統和Anchor Man®左心耳導引系統均爲公司附屬公司上海佐心醫療科技有限公司("上海佐心")自主研發的產品。Anchor Man®左心耳封堵器系統預期用於左心耳的經皮經導管封堵,以預防左心耳血栓栓塞。Anchor Man®左心耳導引系統與Anchor Man®左心耳封堵器系統兼容,可提供股靜脈及經房間隔通路。Anchor Man®左心耳封堵器系統和Anchor Man®左心耳導引系統均已獲得中華人民共和國國家藥品監督管理局頒發的批準。Anchor Man®左心耳封堵器系統是目前中國唯一獲批的半封閉型左心耳封堵器產品。

Anchor Man®左心耳封堵器系統和Anchor Man®左心耳導引系統獲得CE標誌批準,意味着其創新的研發設計和優異的臨牀表現達到了國際水平,爲其進軍歐洲結構性心臟病市場提供了先決條件,亦爲其拓展更多國際市場提供了強有力的支撐,是本公司發展歷程和全球化戰略佈局中至關重要的里程碑,有望進一步拓寬公司收入來源,提升其全球綜合競爭力,併爲公司在國際舞臺上贏得更多機遇,造福更多結構性心臟病患者。

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