Core Viewpoint - The company received approval from the National Medical Products Administration of China for the AcoArt Canna® drug-coated balloon catheter, indicating a significant advancement in its product offerings for treating coronary artery bifurcation lesions [1] Group 1: Product Approval - The AcoArt Canna® is approved for the treatment of primary coronary artery bifurcation lesions with vessel diameters between 2.0mm and 4.0mm [1] - The approval is set to take effect on July 31, 2025, allowing the company to initiate marketing activities in China [1] Group 2: Clinical Trial Results - Clinical trial results demonstrated the effectiveness and safety of AcoArt Canna®: the primary endpoint showed a target lesion branch vessel diameter stenosis (DS) rate of 30.52% at 9 months post-operation for the trial group [1] - The control group, which used a paclitaxel drug-coated balloon catheter, had a DS rate of 33.46% at the same time point, with no statistically significant difference between the two groups [1] - Safety data analysis indicated that the trial group did not present any abnormal risks or events compared to the control group [1]
先瑞达医疗-B(06669)：西罗莫司药物涂层冠脉球囊扩张导管AcoArt Canna的注册批准获中国国家药监局批准