ACOTEC-B (06669) announced that on July 31, 2025, the company received registration approval from China's National Medical Products Administration for its sirolimus drug-coated coronary balloon catheter AcoArt Canna®.

AcoArt Canna® is indicated for dilation treatment of primary coronary bifurcation lesion stenosis in vessels with diameters ranging from 2.0mm to 4.0mm. Clinical trial results demonstrated the effectiveness and safety of AcoArt Canna® in clinical applications.

The primary endpoint of the clinical trial was the diameter stenosis rate (DS, %) of target lesion branch vessels shown by angiography at 9 months post-procedure. The trial group using AcoArt Canna® achieved a DS of 30.52% at 9 months post-procedure, while the control group using paclitaxel drug-coated coronary balloon catheter recorded a DS of 33.46% at 9 months post-procedure. There was no statistical difference between the two groups.

Based on clinical safety data analysis, the trial group showed no abnormal risks or adverse events compared to the control group. The company will launch marketing activities in China at an appropriate time.