Two MicroPort® EP Products Counted in Ten Innovative Medical Devices Gaining CFDA Approval in 2016
Beijing, China – China Food and Drug Administration ("CFDA") recently released the 2016 Annual Report for Medical Device Registration ("the Report") to summarize the overview of medical device registration in 2016. According to the Report, a total of ten innovative medical devices obtained the CFDA approval and two of them are in-house developed by Shanghai MicroPort EP MedTech Co., Ltd. ("MicroPort® EP") - Columbus™ 3D EP Navigation System ("Columbus™") and FireMagic™ Irrigated Ablation Catheter ("FireMagic™").
The Report briefed the review and approval progress for innovative medical devices in 2016. Specifically, the CFDA received 197 applications for the fast-track review and approval procedure for innovative devices, assigned experts to review 175 applications, completed reviewing 144 applications (including those submitted in 2015), accepted 45 medical devices to enter the fast-track review and approval procedure, and approved the launch of ten products including Columbus™ and FireMagic™, one more than 2015. Among the ten products, there are six active medical devices, three passive medical devices, and one in vitro diagnostic reagent.
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 FireMagic™, Columbus™ provides physicians with a comprehensive solution for the radiofrequency ablation treatment of complex arrhythmias. MicroPort® EP owns the invention patent of the core technology of the two devices and their main working philosophy/mechanism is the first-of-its-kind in China with outstanding clinical value. In 2015, Columbus™ and FireMagic™ entered the CFDA fast-track review and approval procedure for innovative medical devices and gained CFDA approval in 2016. With them, MicroPort® EP successfully offers 3D solutions for physicians.
In 2016, MicroPort® EP's 2D solutions, including FireMagic™ Cardiac RF Ablation Catheter and EasyFinder™ Electrophysiology Diagnostic Catheter, and 3D solutions, including Columbus™ and FireMagic™, received regulatory approval in Brazil, Argentina and South Korea. These products had been used in many European and Latin American countries and were highly recognized by domestic and international EP physicians. In April 2017, its in-house developed Flashpoint™ Renal Artery RF Ablation Catheter also entered the CFDA fast-track review and approval procedure for innovative medical devices, which will largely shorten the approval time. MicroPort® EP will continue to strive for innovation and perfection to provide ideal arrhythmia solutions for physicians and patients.
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