佰仁医疗射频消融系统进入创新医疗器械特别审查程序

Core Viewpoint - The announcement indicates that Baifen Medical's self-developed radiofrequency ablation system has received approval from the National Medical Products Administration to enter the special review process for innovative medical devices [1] Group 1: Product Details - The radiofrequency ablation system consists of three products: an ablation instrument, an ablation forceps, and an ablation pen [1] - This system is specifically designed for the surgical treatment of persistent and permanent atrial fibrillation [1] Group 2: Technical Approach - The product is based on traditional maze surgery principles and employs an open-heart surgical method to electrically isolate cardiac tissue [1] - The system aims to create transmyocardial, continuous, and irreversible linear lesions to eliminate atrial fibrillation triggers and maintain the substrate, ultimately restoring sinus rhythm [1]