Shanghai, China – On April 1, Flashpoint™ Renal Artery RF Ablation Catheter ("Flashpoint™ Catheter "), in-house developed by Shanghai MicroPort EP MedTech Co., Ltd. ("MicroPort® EP"), was granted the Green-Path by the China Food and Drug Administration ("CFDA"), a special fast-track procedure for innovative medical devices to gain CFDA approval. Combined with Renal Artery RF Generator and Irrigation Pump, Flashpoint™ Catheter is indicated for the treatment of drug resistant hypertension by renal artery sympathetic denervation. Its CFDA Green-Path may shorten the approval time so that Flashpoint™ Catheter will be launched in the market earlier than expected to benefit patients with drug resistant hypertension.
The innovative Green-Path for CFDA approval was an 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. In 2015, MicroPort® EP's Columbus™ 3D EP Navigation System and FireMagic™ 3D Irrigated Ablation Catheter also gained the CFDA Green-Path.