Core Viewpoint - The company, Xianruida Medical-B (06669.HK), has received approval from the National Medical Products Administration of China for the registration of its drug-coated balloon catheter, AcoArt Canna®, intended for the treatment of coronary artery bifurcation lesions [1] Group 1: Product Approval - AcoArt Canna® is approved for use in patients with a vessel diameter of ≥2.0mm and ≤4.0mm [1] - The approval is significant as it allows the company to market the product in China starting from July 31, 2025 [1] Group 2: Clinical Trial Results - Clinical trial results demonstrated the effectiveness and safety of AcoArt Canna® [1] - The primary endpoint of the trial was the diameter stenosis rate (DS, %) of the target lesion branch at 9 months post-operation, with the trial group showing a DS of 30.52% compared to 33.46% in the control group using paclitaxel-coated balloon catheters [1] - No statistically significant difference was observed between the two groups regarding the DS rates [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 approval [1]
先瑞达医疗-B(06669.HK)：西罗莫司药物涂层冠脉球囊扩张导管ACOART CANNA®的注册申请获中国国家药品监督管理局批准