先瑞达医疗:椎动脉紫杉醇涂层球囊扩张导管获批

美港电讯
04 Jun

【先瑞达医疗:椎动脉紫杉醇涂层球囊扩张导管获批】金十数据6月4日讯,先瑞达医疗公告,集团收到中国国家药品监督管理局对椎动脉紫杉醇涂层球囊扩张导管AcoArtVerbena的注册批准。该产品用于狭窄程度≥70%的椎动脉起始段狭窄,且经药物治疗后有椎基底供血区域症状反复发作的症状性椎动脉颅外段狭窄患者进行经皮腔内血管成形术(PTA)。临床试验结果显示,使用AcoArtVerbena的试验组术后12个月的靶病变再狭窄率为13.04%,显著低于对照组的37.31%,优效的统计推断成立。

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