MicroPort® EP Obtains CFDA Approval for Columbus® 3D EP Navigation System (2.0)
Shanghai, China – On May 18, Shanghai MicroPort EP MedTech Co., Ltd. ("MicroPort® EP") obtained the registration certificate of China Food and Drug Administration ("CFDA") for its in-house developed Columbus® 3D EP Navigation System (2.0).
As the first domestic magnetic navigation system, Columbus® uses delicate catheters to map atriums and ventricles. With self-developed mapping/ablation catheters and reference patch from MicroPort® EP, system can show real-time 3D images of cardiac chambers after collecting and analyzing electrophysiological activities. Compared to Columbus® (1.0), the 2.0 model has more convenient and efficient clinical functions: (1) Rapid modeling; Real-time mapping (RTM); (2) Multi-catheter display, multiple positioning catheters can be displayed at the same time; (3) Multi-events recording, to view records of ablation events, stimulation events, and etc during produces; (4) Foot pedaling, to facilitate the physician's operation.
Columbus® (1.0) gained the CE certificate in 2013, and it is the only domestically made 3D EP navigation system with the CE certificate. In 2016, Columbus® (1.0) was granted the CFDA approval. With the CFDA approval of Columbus® (2.0), it will provide more safe, effective, and affordable solution for patients with arrhythmias. As the only domestic company that provides a complete solution of cardiac EP treatment, MicroPort® EP will continue to strive for innovation and perfection to provide better arrhythmia solutions for patients and physicians.
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