返回 A A A Font Size Receive E-mail Alerts Press Releases

Two MicroPort® EP Products Counted in Ten Innovative Medical Devices Gaining CFDA Approval in 2016

[2017-04-21] 

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.

About MicroPort®

MicroPort Scientific Corporation (the "Group") is a leading medical device company with business focusing on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 15 seconds in thousands of major hospitals around the world, the Group maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort® is dedicated to becoming a patient oriented global enterprise improve and reshape patient lives through application of innovative science and technology.

For more information, please refer to: www.microport.com

Forward-Looking Statements

Some information contained on this website contains forward-looking statements. These forward-looking statements include, without limitation, those regarding our future financial position, our strategy, plans, objectives, goals and targets, future developments in the markets where we participate or are seeking to participate, and any statements preceded by, followed by or that include the words "believe", "intend", "expect", anticipate", "project", "estimate", "predict", "is confident", "has confidence" and similar expressions are also intended to identify forward-looking statements. Such statements are based upon the current beliefs and expectations of MicroPort®'s management and are subject to significant risks and uncertainties. MicroPort Scientific Corporation undertakes no obligation to update any of the statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors that could cause actual future results to differ materially from current expectations include, but are not limited to, general industry and economic conditions, PRC governmental policies and regulations relating to the medical device manufacturing industry, competition in the medical device manufacturing industry, our ability to develop new products and stay abreast of market trends and technological advances, our goals and strategies, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, fluctuations in general economic and business conditions in China.

This document is for information purposes only and does not constitute or form part of any offer or invitation to sell or the solicitation of an offer or invitation to purchase or subscribe for any securities of MicroPort Scientific Corporation, and no part of it shall form the basis of, or be relied upon in connection with, any agreement, arrangement, contract, commitment or investment decision in relation thereto whatsoever.

All rights reserved.
Copyright © 2017 MicroPort Scientific Corporation

CONTACT:
Amanda Zhang
Corporate Culture & Public Relations Director
Shanghai MicroPort Medical (Group) Co., Ltd. (HQ)
Tel: (86)(21) 38954600-6989
Email: spokesperson@microport.com

 

[Prev]:MicroPort® Endovascular Listed as "2016 Shanghai Pudong New Area Enterprise R&D Institution"
[Next]:MicroPort® Awarded Shanghai Pudong New Area Top 20 Outstanding Contributor to Advanced Manufacturing Industry