Columbus® Granted CFDA Registration Certificate

Shanghai, China – Shanghai MicroPort EP MedTech Co ("MicroPort^® EP") recently received the registration certificate of China Food and Drug Administration ("CFDA") for its in-house developed Columbus^® 3D EP Navigation System ("Columbus^®").

Columbus^®, which provides information about the electrical activity of the heart and catheter location in real time, is designed for the diagnosis of arrhythmias and acts as guidance for catheter ablation.

Columbus^® is the first domestically developed 3D EP navigation system that features real time electromagnetic device tracking with cardiac motion compensation. It offers vivid 3D simulation of the catheter deflectable segment and accurate geometric reconstruction of intra cardiac chambers. With the help of MicroPort^® EP's FireMagic^® Cool 3D Irrigated Ablation Catheter that shows precise location of the catheter curve in the body, Columbus^® provides physicians with a comprehensive solution for the radiofrequency ablation treatment of complex arrhythmias. It also features powerful workstation with integrated ECG recording module, automatic 3D image segmentation of cardiac chambers with one mouse click, and accurate preoperative CT image registration and integration. Meanwhile, the system is all Chinese interface and easy to operate.

Columbus^® was granted CE approval in 2013 and is the only domestically made 3D EP navigation system with the CE certificate. So far it has been exported to Spain, Turkey and Greece and has gained high market recognition. With its launch in the China market, MicroPort^® EP will offer more solutions for patients with cardiac arrhythmias in the country.