Core Viewpoint - The approval of AcoArt Canna by the National Medical Products Administration of China is a significant milestone for the company, potentially enhancing its market position in the cardiovascular medical device sector [1] Company Summary - The stock of Xianruida Medical-B (06669) increased by over 4%, specifically by 4.63%, reaching HKD 11.97 with a trading volume of HKD 6.2497 million [1] - The company has received registration approval for its sirolimus drug-coated balloon catheter, AcoArt Canna, which is intended for the treatment of primary coronary bifurcation lesions with a vessel diameter between 2.0mm and 4.0mm [1] Clinical Trial Results - Clinical trial results demonstrated the effectiveness and safety of AcoArt Canna, with the primary endpoint being the diameter stenosis rate (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 paclitaxel drug-coated balloon catheters, 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] Marketing Plans - The company plans to initiate marketing activities in China at an appropriate time following the approval [1]
港股异动 | 先瑞达医疗-B(06669)涨超4% 近日西罗莫司药物涂层冠脉球囊扩张导管AcoArt Canna®注册获批