Portfolio News

2025/08/01
MicroPort EverPace’s IceMagic™ CryoAblation System Receives EU MDR Certification

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:

  • IceMagic™CryoAblation Console
  • IceMagic  CryoAblation Catheter
  • IceMagic EasyLoop™Mapping Catheter
  • PathBuilder  Advance Steerable Introducer

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.