Core Viewpoint - The approval of AcoArt Canna, a sirolimus drug-coated balloon catheter, by the National Medical Products Administration of China marks a significant milestone for the company in expanding its product offerings in the cardiovascular market [1] Group 1: Product Approval - The company received registration approval for AcoArt Canna on July 31, 2025, from the National Medical Products Administration of China [1] - AcoArt Canna is designed for the treatment of primary coronary bifurcation lesions with vessel diameters ranging from 2.0mm to 4.0mm [1] Group 2: Clinical Trial Results - Clinical trial results demonstrated the efficacy and safety of AcoArt Canna, with the primary endpoint being the diameter stenosis (DS, %) of the target lesion branch at 9 months post-operation [1] - The trial group using AcoArt Canna showed a DS of 30.52% at 9 months, compared to 33.46% in the control group using a paclitaxel drug-coated balloon, with no statistically significant difference between the two groups [1] - Safety data analysis indicated that the trial group did not present abnormal risks or events compared to the control group [1] Group 3: Marketing Plans - The company plans to initiate marketing activities in China at an appropriate time following the product approval [1]

先瑞达医疗-B(06669)发布公告，于2025年7月31日，集团收到中国国家药品监督管理局对西罗莫司药物 涂层冠脉球囊扩张导管AcoArt Canna的注册批准。AcoArt Canna用于血管直径≥2.0mm且≤4.0mm的原发 冠状动脉分叉病变狭窄的扩张治疗。临床试验结果证明了AcoArt Canna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靶病变分支血管直径狭窄率(DS,%)，使用 AcoArt Canna的试验组在术后9个月的D.S.为30.52%，使用紫杉醇药物涂层冠脉球囊扩张导管的对照组 在术后9个月的D.S.为33.46%，两组数据无统计学差异;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。 ...