China CMDE released the Technical Review Report for Registration of Intravascular Shock Wave Therapy Devices on January 11, 2024. This is a Class III device applied by Lepu (Beijing) Medical Device Co., LTD.
The products are used for the pretreatment and balloon dilation of primary coronary artery calcified lesions in adult patients, and the main benefit is to provide patients with an additional means of calcified lesion treatment. The main risks are those associated with surgery in clinical use, especially the risk of calcified plaque detachment resulting from shock waves, unnecessary use or improper handling.