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Shanghai, China – On February 13, Shanghai MicroPort EP MedTech Co., Ltd. (“MicroPort EP”) obtained the registration certificate of Ministry of Food and Drug Safety ("MFDS") for its in-house developed FireMagic™ Cardiac RF Ablation Catheter, EasyFinder™ Fixed Curve Diagnostic Catheter. Meanwhile, MicroPort® EP also obtained the certificate of GMP for MFDS system audit, and the valid period is for 3 years.
FireMagic™ Cardiac RF Ablation Catheter, EasyFinder™ Fixed Curve Diagnostic Catheter and related cables are indicated for use in the diagnosis and treatment of arrhythmia.
FireMagic™ Cardiac RF Ablation Catheter is a flexible and insulative catheter with a deflectable tip comprised of thermoplastic elastomer and several platinum electrodes, and in the tip a thermocouple temperature sensor is embedded. All of the electrodes may be used for cardiac mapping and stimulation purposes; besides, the tip electrode may also be used for ablation,it’s used for monopolar ablation. For ablation, this catheter is used in conjunction with a RF generator and a dispersive electrode (reference electrode), and the large tip electrode delivers radiofrequency current from the radiofrequency lesion generator to the desired ablation site. According to the curve shape and the length of deflectable section, the catheter can be divided into six different specifications, to help doctors to perform accurate positioning within different parts of the ventricle. Depending on the hardness of the catheter shaft, FireMagic™ Cardiac RF Ablation Catheter can be divided into two major categories, the standard type and the strong support type. The strong support type may provide extra stable support ability when used to ablate near tricuspid valve area.
EasyFinder™ Fixed Curve Diagnostic Catheter has a high-torque shaft with an array of platinum electrodes at the distal tip. The platium electrodes are used in cardiac electorphysiological mapping, recording and stimulation. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The tip section of EasyFinder™ Fixed Curve Diagnostic Catheter has a preformed curve to access to target mapping site easily. EasyFinder™ Fixed Curve Diagnostic Catheter has many specifications for doctor to choose in accordance with the size of cardiac chambers, the approaching path and the site to be mapped.
The MFDS approval of FireMagic™ Cardiac RF Ablation Catheter, EasyFinder™ Fixed Curve Diagnostic Catheter signifies that the devices officially enters in the Korea market to lay the foundation for further development of the Asia Pacific market.
