Recently, the innovative products Disposable Cardiac Pulsed Electric Field Ablation Catheter and Cardiac Pulsed Electric Field Ablation System of Sichuan Jinjiang Electronic Medical Device Technology Co., Ltd. were approved by China NMPA.
The disposable cardiac pulsed electric field ablation catheter consists of a catheter and a connecting cable, and the cardiac pulsed electric field ablation system consists of a host, output box and accessories, which is the first cardiac pulsed electric field ablation product in China.
The above two products are used in combination to selectively generate irreversible electroporation damage to the myocardial cells at the lesion site to be treated by controlling and releasing the pulsed electric field energy with appropriate intensity, to achieve the purpose of treating atrial fibrillation and provide more options for the treatment of drug refractory, recurrent, symptomatic and paroxysmal atrial fibrillation.
The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.