Innovative Product Cryoablation Apparatus Approved for Marketing
Recently, the innovative product Cryoablation Apparatus of Synaptic Medical Technology (Beijing) Co., Ltd. is approved by China NMPA.
This product consists of the main unit, coaxial fluid connecting tubes, and connection cables. It is designed for use in combination with the company’s balloon-type cryoablation catheter. Utilizing pressure-flow dual control technology, the system monitors and controls the flow of refrigerant and balloon pressure in real time, ensuring stable pressure during both inflation and ablation processes. This technology effectively reduces the risk of balloon displacement caused by pressure fluctuations during pulmonary vein occlusion and ablation, making it suitable for the treatment of adult patients with drug-resistant, recurrent, symptomatic paroxysmal atrial fibrillation.
The NMPA will strengthen the post-marketing surveillance of the product to ensure the safe use of this medical device.