Recently, the innovative products Cryoablation Equipment and Balloon Cryoablation Catheter of Cryofocus Medtech (Shanghai) Co., Ltd. are approved by China NMPA.

The Cryoablation Equipment consists of a freezing unit, a vacuum system, a cryogenic working fluid delivery circuit, and a control system. On the other hand, the Balloon Cryoablation Catheter consists of a device connection part, an operation control part, and a blood contact part. These two products are used in combination in medical institutions for the treatment of drug-refractory, recurrent, symptomatic, and paroxysmal atrial fibrillation.

During the treatment, the Cryoablation Equipment delivers nitrogen gas to the inner lumen of the balloon after it is cooled by a heat exchanger, enabling the balloon to make contact with the tissue at a low temperature. Additionally, it dynamically adjusts the pressure and flow of the freezing medium based on the temperature feedback from the catheter to maintain the surface temperature of the balloon within the specified range. Simultaneously, the vacuum pump of the equipment continuously extracts air from the outer pipeline of the catheter, achieving a high vacuum insulation state in the outer pipeline of the product, ensuring the safety of the non-ablation area and therefore improving the safety of the surgery.

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