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心通醫療-B(02160.HK):成功於阿根廷註冊VitaFlow Liberty™經導管主動脈瓣植入系統
格隆匯 01-05 22:46

格隆匯1月5日丨心通醫療-B(02160.HK)宣佈,公司成功於阿根廷註冊VitaFlow Liberty經導管主動脈瓣植入系統("VitaFlow Liberty™")。VitaFlow Liberty是公司的第二代經導管主動脈瓣植入術("TAVI")產品,也是繼公司的一代TAVI產品VitaFlow®之後,第二個在阿根廷註冊的產品。

VitaFlow Liberty™於2021年8月30日已獲得中華人民共和國國家藥品監督管理局的註冊批准,並於2021年12月28日完成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)註冊申請。

與公司的第一代TAVI產品相比,VitaFlow Liberty的關鍵升級在於輸送系統,其獨家的創新雙筋螺旋結構保證其在實現PAV(人工主動脈瓣)可回收功能的同時,提供優異的通過性能,從而有助於通過嚴苛的解剖結構。其配以全球唯一已上市電動手柄,實現快速穩定且精準的釋放及回收,亦是目前中國市場上唯一可實現瓣膜段360度彎曲功能的輸送系統。

和VitaFlow Liberty一起於阿根廷註冊的還有我們的第一代尖端預塑型超硬導絲Angelguide®,其具有高導絲導軌支撐和平滑過渡的特點,以減少血管損傷及提升釋放精準性。此外,VitaFlow Liberty創新性地引入內聯導管鞘設計,以擴大患者血管適配範圍。

公司認為,VitaFlow Liberty在阿根廷註冊,標誌着公司的國際化佈局邁出了又一堅實步伐,公司將立即着手VitaFlow Liberty在阿根廷的推廣,讓公司的優秀產品造福當地心臟瓣膜疾病患者。

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