Xianruida Medical-B (06669): Application for registration of ACOART VERBENA®, a vertebral paclitaxel coated balloon dilatation catheter was approved by the China National Drug Administration

Zhitong Finance App News, Xianruida Medical-B (06669) issued an announcement. On May 30, 2025, the Group received approval from the China National Drug Administration for registration of ACoART Verbena®, a vertebral artery paclitaxel coated balloon dilatation catheter. ACoArt Verbena® is used for percutaneous intracranial angioplasty (PTA) in patients with symptomatic vertebral artery extra-cranial stenosis with recurrent episodes of symptoms in the vertebral basal blood supply area after treatment with a degree of stenosis greater than 70% of the vertebral artery. Clinical trial results proved the efficacy and safety of ACoArt Verbena® in clinical use: the main endpoint of the clinical trial was the target lesion re-stenosis rate 12 months after surgery. The test group using ACoArt Verbena® was 13.04%, significantly lower than 37.31% of the control group. This result was an effective statistical inference based on satisfying the hypothesis of non-poor efficacy. Stenosis at the beginning of the vertebral artery is one of the key risk factors for post-circulatory ischemic stroke. Timely treatment is of positive significance in preventing the occurrence and recurrence of stroke. The approval of ACoArt Verbena® will usher in a new era of “no intervention” in vertebral artery stenosis treatment. The company will launch marketing activities in China in due course.