Recently, the innovative product FireMagic™ TrueForce™ Ablation Catheter of Shanghai MicroPort EP MedTech Co., Ltd. is approved for marketing by China NMPA.

　　The product consists of a radiofrequency ablation catheter, a connection cable, and a connection box. The main body of the catheter has a high-torque shaft with a uni-directional deflectable tip section containing an array of electrodes. This product is used in conjunction with Columbus™ 3D EP Navigation System and OptimAblate™ Cardiac RF Generator of Shanghai MicroPort EP MedTech Co., Ltd. for the treatment of refractory, recurrent, symptomatic and paroxysmal Atrial Fibrillation.

　　This product uses contact force sensing technology based on strain gauge principle, magnetic field positioning technology, saline perfusion technology and three-dimensional electrophysiological mapping system, which can provide an overall solution for the treatment of atrial fibrillation patients. It is the first domestic cardiac radiofrequency ablation catheter with contact force sensing function in China. Compared with the traditional cardiac radiofrequency ablation catheter, this product can provide a real-time measurement of contact force between the catheter tip and heart wall, which can better assist the surgeon to complete the operation, effectively avoid either steam burst caused by the excessive contact force between the catheter and tissue or incomplete ablation by too small contact force during the operation, shorten the doctor's learning curve, and achieve a better long-term success rate of treatment.

　　The approval of this product is conducive to the clinical application and promotion of this technology, reducing the cost of clinical treatment, and benefiting more AF patients.

　　The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.

　　Annex: Innovative medical devices approved by NMPA