Recently, the innovative product "Cryoablation Console" of Shanghai Antec Medical Technology Co., Ltd. is approved by China NMPA.

This product consists of a balloon cryoablation catheter, and a manual retractor, and is used in conjunction with a specific cryoablation device for the treatment of adult patients with medically refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

The product features a "32 mm large balloon" and an "8 mm short tip" design, which allows for stable control of refrigerant flow, effective temperature management, and close proximity to the pulmonary vein ostium. This design enables the effective collection of pulmonary vein potentials, ensuring the efficacy of cryoablation. Compared to similar domestic and international products available in China, this technology is pioneering. The market release of this product will further meet the clinical needs in the treatment of paroxysmal atrial fibrillation in China.

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