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

ACOTEC-B(06669) announced that on July 31, 2025, the group received approval from the China National Medical Products Administration for the registration of the AcoArt Canna drug-coated coronary balloon dilatation catheter for the treatment of narrowing lesions in primary coronary artery bifurcations with a vessel diameter of 2.0mm and 4.0mm. Clinical trial results have demonstrated the efficacy and safety of AcoArt Canna in clinical applications. The primary endpoint of the clinical trial was the percentage of narrowness in the target lesion branch vessel diameter on angiography at 9 months postoperatively (DS, %), with the trial group using AcoArt Canna having a DS of 30.52% at 9 months postoperatively, while the control group using paclitaxel drug-coated coronary balloon dilatation catheter had a DS of 33.46% at 9 months postoperatively, with no statistical difference between the two groups. Based on the analysis of clinical safety data, the trial group did not exhibit any abnormal risks or events compared to the control group. The company will carry out marketing activities in China in a timely manner.