先瑞達醫療-B(06669.HK):國家藥監局批准AcoArt Orchid & Dhalia適應症擴展
格隆匯7月13日丨先瑞達醫療-B(06669.HK)公佈,於2022年7月7日,公司收到中國國家藥品監督管理局對治療動靜脈內瘻(AVF)狹窄的AcoArt Orchid & Dhalia的適應症擴展的最新註冊證書。
公司於2018年5月啟動用於在中國治療AVF狹窄的AcoArt Orchid & Dhalia的隨機對照臨牀試驗以評估其安全性及效用,並已完成所有受試者的六個月隨訪及十二個月隨訪。根據六個月隨訪的數據,藥物塗層球囊(DCB)組的通暢率為91.4%,而經皮腔內血管形成術(PTA)組的通暢率則為66.9%。根據十二個月隨訪的數據,DCB組的通暢率為66.1%,而PTA組的通暢率則為46.4%。
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