Sinocare Medical-B (06669): The registration approval of the AcoArt Canna drug-coated coronary balloon dilatation catheter with sirolimus coating was approved by the China National Medical Products Administration.

Zhichuan Finance and Economics APP news, Xianruida Medical-B(06669) announced that on July 31, 2025, the group received the registration approval of AcoArt Canna coronary artery balloon dilatation catheter with sirolimus drug coating from the China National Medical Products Administration. AcoArt Canna is used for the dilation treatment of primary coronary artery bifurcation stenosis with a vessel diameter 2.0mm and 4.0mm. Clinical trial results have proven the effectiveness and safety of AcoArt Canna in clinical application: the main endpoint of the clinical trial was the percentage of diameter stenosis (DS, %) of the target lesion branch vessel shown on vascular angiography at 9 months postoperatively. The DS in the group using AcoArt Canna at 9 months postoperatively was 30.52%, while the DS in the control group using paclitaxel drug-coated coronary artery balloon dilatation catheter at 9 months postoperatively was 33.46%, and the two sets of data showed no statistical difference; based on clinical safety data analysis, the test group did not show abnormal risks or events compared to the control group. The company will conduct marketing activities in China in due course.