先瑞達醫療-B(06669.HK):西羅莫司藥物塗層冠脈球囊擴張導管ACOART CANNA®的註冊申請獲中國國家藥品監督管理局批准
格隆匯8月4日丨先瑞達醫療-B(06669.HK)發佈公吿,於2025年7月31日,集團收到中國國家藥品監督管理局對西羅莫司藥物塗層冠脈球囊擴張導管AcoArt Canna®的註冊批准。AcoArt Canna®用於血管直徑≥2.0mm且≤4.0mm的原發冠狀動脈分叉病變狹窄的擴張治療。臨牀試驗結果證明了AcoArt Canna®在臨牀應用的有效性和安全性:臨牀試驗的主要終點指標為術後9個月時血管造影顯示的靶病變分支血管直徑狹窄率(DS, %),使用AcoArt Canna®的試驗組在術後9個月的D.S.為30.52%,使用紫杉醇藥物塗層冠脈球囊擴張導管的對照組在術後9個月的D.S.為33.46%,兩組數據無統計學差異;而基於臨牀安全性數據分析,試驗組相對於對照組也並未呈現出異常風險及事件。公司將適時在中國開展營銷活動。
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