蓝帆医疗股份有限公司 关于子公司LithonicTM冠脉血管内冲击波治疗系统获得CE证书的公告

Core Viewpoint - The company, Bluestar Medical Co., Ltd., has received EU CE certification for its LithonicTM Coronary Intravascular Lithotripsy system, marking a significant advancement in the treatment of calcified lesions in coronary arteries [1][2]. Group 1: Product Information - Product Name: LithonicTM Coronary Intravascular Lithotripsy (IVL) Catheter / Generator [1] - Manufacturer: Biosensors Interventional Technologies Pte. Ltd. (Singapore) [1] - Validity Period: Until January 13, 2031 [1]. Group 2: Product Description - The LithonicTM system utilizes high-pressure sound waves to treat severely calcified narrow areas in blood vessels, particularly where balloon dilation or stent expansion is ineffective [1]. - The system operates on the principle of electrolysis in an electrolyte solution, allowing precise release of high-pressure shock waves to modify calcified lesions and reduce complications associated with traditional treatment methods [1]. Group 3: Impact on the Company - The IVL technology is emerging as a preferred clinical option for treating calcified lesions due to its unique mechanism of action [2]. - The CE certification enhances the company's technological leadership in the coronary field and is expected to positively impact the company's operational development and overall competitiveness in the cardiovascular sector [2].