Disposable Cardiac Pulse Field Ablation Catheter Approved By China NMPA


2024-03-26

On March 11, 2024, the China NMPA approved an innovative product registration application for a disposable cardiac pulse field ablation catheter.

Comprised of a catheter and connecting cables, this product is designed to be used in conjunction with the company’s manufactured cardiac pulse field ablation device. By controlling and releasing pulse field energy of appropriate intensity, it selectively induces irreversible electric perforation damage only to the myocardial cells in the lesion area requiring treatment, thereby achieving the goal of treating atrial fibrillation. This product offers additional options for the treatment of drug-resistant, recurrent, symptomatic, and paroxysmal atrial fibrillation.

Regulatory authorities will strengthen supervision over the product post-market approval to ensure patient safety.

For further inquiries regarding medical device registration, please contact: info@bradyknowsmedical.com.