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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.
