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先瑞達醫療-B(06669.HK):就AcoArt Litos™紫杉醇塗層經皮腔內血管成形術(PTA)球囊導管向美國FDA遞交IDE申請
格隆匯 01-28 21:25

格隆匯1月28日丨 先瑞達醫療-B(06669.HK)宣佈,公司近期就AcoArt Litos紫杉醇塗層經皮腔內血管成形術(PTA)球囊導管("AcoArtLitos™")向美國食品藥品監督管理局("美國FDA")設備和輻射健康中心遞交研究性器械豁免("IDE")申請。

AcoArtLitos是一種紫杉醇藥物塗層(DCB),用於防止膝下(BTK)動脈狹窄或閉塞,以血管介入法治療慢性肢體缺血。公司於2014年就Aco ArtLitos獲得CE認證、於2019年就Aco ArtLitos獲得美國FDA"突破性器械"稱號、於2020年12月就AcoArt Litos獲得國家藥品監督管理局上市批准,併成功於2021年1月於中國市場推出。根據弗若斯特沙利文的資料,AcoArtLitosTM是第一款獲得美國FDA"突破性器械"稱號的國產器械。

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