Recently, the innovative products FARAWAVE Pulsed Field Ablation Catheter and FARASTAR Pulsed Field Ablation Generator System of Farapulse, Inc. is approved for marketing by China NMPA.

The FARAWAVE Pulsed Field Ablation Catheter consists of a Pulsed Field Ablation Catheter and a Catheter Connection Cable. The FARASTAR Pulsed Field Ablation Generator System consists of a pulsed electric field ablator, a recording module, and accessory cables. These two products are used in combination for the treatment of drug-refractory, recurrent and symptomatic paroxysmal atrial fibrillation in patients.

The product utilizes the principle of the non-thermal effect of the pulsed electric field to treat atrial fibrillation. It can achieve the selective destruction of myocardial tissue and avoid the risk of damage to surrounding tissues caused by heat transfer.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.