Farapulse, Inc. Receives NMPA Approval for Single-Use Cardiac Pulsed Field Ablation Catheter and Cardiac Pulsed Field Ablation System

Recently, the National Medical Products Administration approved the registration applications of two innovative products from Farapulse, Inc.: the "Single-Use Cardiac Pulsed Field Ablation Catheter" and the "Cardiac Pulsed Field Ablation System."

The disposable cardiac pulse field ablation catheter consists of a cardiac pulse field ablation catheter and a catheter connection cable. The cardiac pulse field ablation system is composed of a pulse field ablation device, a recording module, and accessory cables. These two products are used together for the treatment of patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

This product utilizes the non-thermal effects of pulsed electric fields for atrial fibrillation treatment, enabling selective destruction of myocardial tissue while avoiding the risk of damage to surrounding tissues caused by heat transfer.

The pharmaceutical regulatory authorities will strengthen the post-marketing supervision of this product to protect the safety of patients using medical devices.

Source: National Medical Products Administration