FireMagic™ 3D Gains CFDA Approval

Shanghai, China – On May 8, Shanghai MicroPort EP MedTech Co., Ltd. ("MicroPort® EP") obtained a registration certificate from China Food and Drug Administration ("CFDA") for its in-house developed FireMagic™ 3D Ablation Catheter ("FireMagic™ 3D"). The device is designed for cardiac electrophysiological mapping. Combined with radio frequency ablation device, FireMagic™ 3D is indicated for use in treating ECG proven arrhythmia with definite clinical symptoms, including AVRT and AVNRT.
 
FireMagic™ 3D has a high-torque shaft with a deflectable curve section. The tip deflection is controlled at the proximal end by a handle. The high-torque shaft also allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. When used with Columbus™ 3D EP Navigation System ("Columbus™"), it provides precise location of the catheter curve in the body. FireMagic™ 3D is a unidirectional catheter with four specifications of different curved shapes to meet patients' requirements.
 
The tip electrode of FireMagic™ 3D is equipped with a magnetic oriented sensor to show the location of the catheter tip, and some specifications have an additional magnetic oriented sensor in the proximal end of the curve section to collect the coordinate data of the curve section. When used with Columbus™, it shows the real-time image of the catheter end curve, guiding physicians to do radiofrequency ablation, and meanwhile reducing X-ray exposure to physicians.
 
President of MicroPort® EP Yiyong Sun said: "The CFDA approval of FireMagic™ 3D signifies a major step forward for MicroPort® EP to provide a complete electrophysiological solution for arrhythmia patients with combinations of active and passive devices and equipment."