Shanghai, China, 22 July 2025 —MicroPort EverPace recently announced that its full-suite IceMagic™ CryoAblation System has received EU MDR certification.
The approved system covers the entire ablation workflow, from transseptal access to occlusion evaluation and energy delivery, ensuring closed-loop procedure through seamless device integration. The system includes:
Among its technological highlights, the IceMagic™ balloon catheter introduces a novel surface temperature monitoring design on the balloon surface, enabling real-time monitoring of tissue contact. The IceMagic™ console features multi-parameter signal control and multi-channel temperature sensing, supporting customizable target temperature presets and built-in temperature control mode to prevent excessive freezing.
Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice. Compared to traditional point-by-point radiofrequency ablation, cryoablation achieves pulmonary vein isolation through continuous, transmural lesions in a simplified and efficient manner. It offers clinical advantages such as shorter procedure time, easier operation, and a flatter learning curve, while maintaining safety and efficacy.
IceMagic™System entered China’s NMPA Fast Track Registration Pathway in June 2021 and was approved for commercial use in August 2023 for the treatment of AF.
This certification is expected to pave the way for the System’s entry into the European market as an integrated cryoablation solution. Looking ahead, MicroPort EverPace will continue accelerating the global rollout of high-end, innovative medical technologies, delivering competitive and comprehensive electrophysiology solutions to physicians and patients worldwide.
About MicroPort EverPace
Founded in 2010, MicroPort EverPace (Shanghai MicroPort EP MedTech Co., Ltd; SSE: 688351), an associated company of MicroPort® (MicroPort Scientific Corporation; HKEX: 00853), is a global medical devices company focusing on the development, manufacturing, and commercializing minimally invasive medical devices for the treatment of cardiac arrhythmia. It has developed a family of advanced cardiac ablation catheters, diagnostic catheters, and 3D navigation systems. These solutions are used by hundreds of physicians at over 1100 hospitals over more than 30 countries. MicroPort EverPace strives to provide integrated therapeutic solutions to apply precise navigation on interventional procedures, dedicated to providing high quality therapeutic solutions to patients and physicians across the globe.
More information is available at: www.everpace.com/en