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心泰醫療(02291.HK):ScienCrown經導管植入式主動脈瓣膜系統取得醫療器械登記證
格隆匯 12-17 19:25

格隆匯12月17日丨心泰醫療(02291.HK)公吿,中國國家藥品監督管理局已授出ScienCrown經導管植入式主動脈瓣膜系統產品(ScienCrown經導管植入式主動脈瓣膜系統)的醫療器械登記證(樂普(北京)醫療器械股份有限公司作為醫療器械註冊人)。

ScienCrown經導管植入式主動脈瓣膜系統結構設計從臨牀實際出發,有效解決了TAVR術中瓣膜擴張不良、定位不準、移位風險、冠狀動脈阻塞等現存難點,實現多項創新突破,並具備多項專利。該產品具有以下特點和優勢:(1)使用抗鈣化牛心包瓣葉,使用耐久性更高;短瓣架不遮擋冠脈開口,不影響冠脈再介入手術,安全有效;(2)自膨直筒設計兼具較強順應性和穩定支撐力,提供更大瓣口面積,有效降低壓差,減少遠期併發症;(3)全掛連接配合預彎型輸送系統,過弓順暢,同軸釋放,可穩定全回收和重複定位,操作便利安全;及(4)經股動脈、經心尖雙入路方式,為介入治療提供更多選擇,滿足臨牀不同需求。

未來,公司將繼續秉承創新精神,深化臨牀合作,不斷優化產品性能,拓展應用場景,為推動心血管介入領域的發展貢獻更多力量,造福患者。

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