MicroPort® EP's Contact Force Sensing RF Ablation Catheter Gains CFDA Green-Path
Shanghai, China – On October 20, Contact Force Sensing RF Ablation Catheter ("Contact Force Catheter"), in-house developed by Shanghai MicroPort EP MedTech Co., Ltd. ("MicroPort® EP"), was approved to enter the special Green-Path by China Food and Drug Administration ("CFDA"), which is rapid-track of review and approval procedure for innovative medical devices.
The Contact Force Catheter is the new-generation of high-end RF Ablation Catheter of MicroPort® EP, indicated for using in cardiac electorphysiological mapping to treat the drug refractory atrial fibrillation when used in conjunction with a radiofrequency generator. In addition, when used in conjunction with Columbus™ 3D EP Navigation System ("Columbus™"), it can provide locating information and real-time measurement of contact force between catheter tip and cardiac wall.
The Green-Path of the Contact Force Catheter demonstrated the recognition of Chinese government authorities in its innovation and will significantly expedite its approval time to further diversify MicroPort® EP's product portfolio, marking another solid step of MicroPort® EP in becoming the provider of "a complete solution platform combining active and nonactive, device and equipment." Other than the Contact Force Catheter, three products of MicroPort® EP also entered the CFDA Green-Path, including Columbus™, FireMagic™ 3D Ablation Catheter ("FireMagic™ 3D"), and Flashpoint™ Renal Artery RF Ablation Catheter. Columbus™ and FireMagic™ 3D received CFDA approval in 2016.
CFDA Green-Path on China's Innovative Medical Devices is critically important approach introduced by the government authority to encourage the innovations of medical devices and promote the application of new technologies in the healthcare industry. Innovative medical devices entering Green-Path procedure will receive preferential review process by Food and Drug Administrations to assign special personnel to process the submissions, which will significantly accelerate the approval process and product launch in market.
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.
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.
Copyright © 2016 MicroPort Scientific Corporation. All rights reserved.
Corporate Culture & Public Relations Director
Shanghai MicroPort Medical (Group) Co., Ltd.
Tel: (86)(21) 38954600-6989