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)：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