智通财经APP讯，先瑞达医疗-B(06669)发布公告，于2025年5月30日，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AcoArt Verbena®的注册批准。 AcoArt Verbena®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)。临床试验结果证明了AcoArt Verbena®在临床应用的有效性和安全性：临床试验的主要终点指标为术后12个月的靶病变再狭窄率，使用AcoArt Verbena®的试验组为13.04%，显着低于对照组的37.31%，这一结果在满足非劣效假设的基础上，优效的统计推断成立。椎动脉起始段狭窄是导致后循环缺血性卒中的关键危险因素之一，及时治疗对于预防卒中的发生和复发具有积极意义。 AcoArt Verbena®的获批，将引领椎动脉狭窄治疗开启“介入无植入”新时代。公司将适时在中国开展营销活动。
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