Seoul, South Korea – On February 13, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") announced that its products FireMagic™ Cardiac RF Ablation Catheter and EasyFinder™ Fixed Curve Diagnostic Catheter received the regulatory approval from the Ministry of Food and Drug Safety ("MFDS") of South Korea. The two products are both in-house developed by MicroPort®'s subsidiary Shanghai MicroPort EP MedTech Co., Ltd. ("MicroPort® EP"). At the same time, MicroPort® EP passed the system audit of MFDS and obtained the certificate of Korea Good Manufacturing Practice ("KGMP"), valid for three years.
FireMagic™ Cardiac RF Ablation Catheter and EasyFinder™ Fixed Curve Diagnostic Catheter are designed for the diagnosis and treatment of arrhythmia. FireMagic™ Cardiac RF Ablation Catheter is a flexible, insulated catheter with a deflectable curve tip. It is composed of medical grade thermoplastic elastic polymer and a number of platinum electrodes. All of its electrodes can be used for cardiac electrophysiology mapping and stimulation, but only the tip electrode has the function of ablation. The FireMagic™ Catheter offers six types of curve shapes to permit accurate positioning in different areas of ventricle. EasyFinder™ Fixed Curve Diagnostic Catheter is consisted of a high-torque shaft and platinum electrodes. The electrodes are used for cardiac electrophysiology mapping and programmed stimulation. Its high-torque shaft allows the plane of the curved tip to be adjusted by manual rotation to facilitate accurate positioning of the catheter tip at the desired site.
The MFDS approval for FireMagic™ Cardiac RF Ablation Catheter and EasyFinder™ Fixed Curve Diagnostic Catheter means the two products will soon enter the South Korea market, laying a great foundation for MicroPort® EP to further expand the Asia-Pacific markets.