Recently, the innovative product Cryoablation Apparatus of Shanghai Antaike Medical Technology Co., Ltd. is approved for marketing by China NMPA.

This product consists of a main unit, a gas extension tube and a balloon catheter tail wire. It is used in combination with specific balloon-type cryoablation catheters for the treatment of drug-refractory, recurrent and symptomatic paroxysmal atrial fibrillation in adult patients.

Compared with similar domestic and foreign products that have been marketed in China, the technologies of "adjustable cooling capacity" and "rewarming reminder" used in this product are pioneering. The "adjustable cooling capacity" technology can monitor the freezing temperature in real time and reduce damage to adjacent tissues on the basis of ensuring the effect of cryoablation treatment. The “rewarming reminder” technology can reduce clinical and operational risks such as myocardial damage to patients caused by premature balloon retraction and difficulties in inserting the balloon into the sheath.

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