佰仁醫療(688198.SH):二尖瓣成形環產品獲批註冊
格隆匯12月21日丨佰仁醫療(688198.SH)公佈,近日,經國家藥品監督管理局審評,公司自主研發的二尖瓣成形環產品註冊申報獲得批准(國械注準20233131974),這是公司現有瓣膜成形環的二尖瓣成形環升級產品,現將有關情況公吿如下:
該產品是在公司原有瓣膜成形環產品大量用於國內患者二尖瓣修復的臨牀實踐經驗的基礎上,採用半硬生理環結構設計和彈性合金材料加工製造,對標進口最新一代二尖瓣成形環,不僅可獲得更好二尖瓣成形效果,同時兼顧瓣膜病患者全生命週期管理理念,適應未來可能需要接續環中瓣再介入治療的需求而研發的升級換代產品。
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