Shanghai, China – Shanghai MicroPort EP MedTech Co ("MicroPort® EP") recently obtained the registration certificate of China Food and Drug Administration ("CFDA") for its in-house developed FireMagic® Irrigated Ablation Catheter ("FireMagic®"). The Columbus® 3D EP Navigation System ("Columbus®"), with which FireMagic® works, was granted the CFDA approval earlier this year. With both of them officially launched, MicroPort® EP provides physicians with a comprehensive solution for the diagnosis and treatment of complex arrhythmias.
FireMagic®, combined with Columbus®, is mainly used in the treatment for drug resistant atrial fibrillation. FireMagic® is equipped with magnetic oriented sensors, and when used with Columbus®, it shows the real-time location and moving direction of the catheter tip in cardiac chambers. It helps to construct 3D anatomical structure of the cardiac chambers by recording the location of the catheter tip, and then to find out the lesion with the navigation function of Columbus®, guiding physicians to do accurate-point and linear ablation, so as to improve the success rate of the operation while reducing X-ray exposure to physicians.
With multiple embedded sensors, FireMagic® realizes real-time curve visualization on Columbus®, which facilitates physicians to sense and judge the status of the catheter in the body. Besides, the open irrigation channel of FireMagic®, which connects with the irrigation hole on the tip electrode, irrigates saline to cool the ablation electrode and keep the tip electrode at a low temperature. Such design will effectively reduce the risk of scabbing, resulting in better efficacy and safety compared to traditional ablation catheter.
The FireMagic® that gains the CFDA approval contains two types: one has 6-hole irrigation (Product Name: FireMagic Cool 3D) and the other has the new micro-hole irrigation (Product Name: FireMagic SuperCool 3D). The FireMagic® with micro-hole irrigation cools the ablation electrode more uniformly, which reduces the irrigated saline used in the operation by half, so as to lower the saline load of patients.
FireMagic® combined with Columbus® was listed under the National High-tech R&D Program (863 Program) and supported by the fund of National Key Technology Support Program. Its key technology was awarded several patents, and was granted the Green Channel status for innovative medical devices to fast track the CFDA approval in 2015. FireMagic® obtained the CE Mark in November, 2013, and has been used in countries including Dominica, Greece, Turkey and Spain, with positive clinical feedback. With its CFDA approval, FireMagic® will officially enter the China market to benefit more domestic patients.