佰仁医疗(688198.SH)：射频消融系统进入创新医疗器械特别审查程序

Core Viewpoint - The company, Bairen Medical (688198.SH), has received approval from the National Medical Products Administration for its self-developed radiofrequency ablation system, allowing it 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 clamp, and an ablation pen [1] - This system is specifically designed for the surgical treatment of persistent and permanent atrial fibrillation [1] Group 2: Technology and Mechanism - The product is based on the traditional maze surgery principle and employs an open-heart surgical approach to electrically isolate atrial tissue [1] - It creates a trans-wall, continuous, and irreversible linear lesion to eliminate the triggers of atrial fibrillation and maintain the substrate, aiming to restore sinus rhythm [1]