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 announcement highlights that the LithonicTM Coronary Intravascular Lithotripsy system has received CE certification, marking a significant advancement for the company in the cardiovascular treatment sector [1][2]. Product Information - The product, LithonicTM Coronary Intravascular Lithotripsy (IVL) Catheter / Generator, is manufactured by Biosensors Interventional Technologies Pte. Ltd. in Singapore and is valid until January 13, 2031 [1]. - The system is designed to treat severely calcified narrow areas in blood vessels by releasing high-pressure sound waves, which helps to modify calcified lesions and reduce the risk of complications associated with traditional treatment methods [1]. Impact on the Company - The CE certification of the LithonicTM system signifies international recognition of its clinical efficacy and safety, enhancing the company's competitive edge in the coronary field [2]. - The innovative IVL technology is becoming a preferred clinical option for treating calcified lesions, which is expected to positively influence the company's operational development [2].