智通财经APP讯，先瑞达医疗-B(06669)公布，于2024年11月29日，该集团收到中国国家药品监督管理局对紫杉醇释放冠脉球囊扩张导管AcoArt Camellia®的注册批准。 AcoArt Camellia®适用于血管直径≥2.0mm且≤2.75mm的原发冠状动脉血管病变治疗。临床试验结果证明了AcoArt Camellia®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9个月时血管造影显示的节段内直径狭窄率(DS,%)，使用AcoArt Camellia®的试验组为31.09%，显著低于对照组的40.32%，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;而基于临床安全性数据分析，试验组相对于对照组也并未呈现出异常风险及事件。公司将适时在中国开展营销活动。
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