Cryofocus Medtech (Shanghai) Co., Ltd. announced that, on December 4, 2023, two key components of its Atrial Fibrillation Cryoablation System, namely, the cryoablation equipment and the balloon cryoablation catheter (formerly known as AF cryoablation catheter, were granted approval by the National Medical Products Administration of the People's Republic of China. The Cryoablation Equipment mainly includes a freezing unit and a control system, with a primary function to deliver cryogen to the Balloon Cryoablation Catheter. The Balloon Cryoablation Catheter is a flexible balloon catheter which mainly includes three parts, namely, a device connection part, an operation control part and a blood contact part.

The AF Cryoablation System will be used for the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation. The Company is the first medical device company to apply cryoballoon with liquid nitrogen as the refrigerant for the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation. Using liquid nitrogen as the refrigerant, the target tissue is rapidly cooled down by the ultra-low temperature generated by the liquid nitrogen, and the ablation range can be controlled to achieve the therapeutic effect of necrosis of aberrant myocardial cells, which greatly improves the effectiveness and safety of the product.

Unlike traditional point- by-point radiofrequency ablation, cryotherapy technology can realize one-time comprehensive ablation, which is safe, effective, convenient and reproducible. The cryoballoon ablation has become one of the standard methods to realize pulmonary vein isolation. The clinical study results of the AF Cryoablation System have been published in Journal of the American College of Cardiology in October 2023 (JACC: Asia.

2023 Oct, 3 (5) 805­816). The Company has overcome many key difficulties in the clinical application of liquid nitrogen cryogen and developed the original liquid nitrogen cryoablation technology in China, which can efficiently isolate pulmonary veins. Combined with ultra-vacuum heat insulation technology, the freezing medium can be transported to a treatment site under low pressure and the balloon temperature can be accurately controlled and monitored in real time, further improving the safety and effectiveness of the AF Cryoablation System.

Meanwhile, in contrast to nitrous oxide (N 2O) as a freezing medium, nitrogen gas is safe, readily available and environmentally friendly, which is better for clinical promotion and application.