Release date: 2023-12-05
Recently, the China NMPA approved the registration application for innovative products “cryoablation equipment” and “balloon cryoablation catheter” produced by Kangfeng Biotechnology (Shanghai) Co., Ltd.
“Cryogenic ablation equipment” consists of a freezing device, a vacuum system, a low-temperature fluid delivery circuit and a control system. The “balloon cryoablation catheter” consists of equipment connection parts, operation control parts and blood contact parts. The above two products are used in conjunction with each other in medical institutions for the treatment of drug-refractory, recurrent, symptomatic, and paroxysmal atrial fibrillation.
During the treatment process, the “cryoablation equipment” can transport nitrogen to the inner cavity of the balloon after being cooled by a heat exchanger, causing the balloon in contact with the tissue to generate low temperature, and dynamically regulate the pressure and flow of the freezing medium through the temperature fed back by the catheter, to maintain the balloon surface temperature within the specified range. At the same time, the vacuum pump of this equipment continuously extracts the air in the outer tube of the catheter, so that the outer tube of the product reaches a high vacuum insulation state, ensuring the safety of the non-ablation area and improving the safety of the operation.
The NMPA will strengthen post-market supervision of this product to protect patient safety.