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Shanghai, China——On August 23rd, Shanghai MicroPort EP MedTech Co., Ltd (referred to as MicroPort EP) received the regulatory approval issued by National Medical Products Administration (NMPA) in China for IceMagic™ CryoAblation Catheter (referred to as CryoAblation Catheter) and IceMagic™ CryoAblation Console (referred to as CryoAblation Console). As the first approved cryoablation products developed and manufactured in China for the treatment of atrial fibrillation (referred to as AF), they have filled in the gap in Chinese cryoablation market. Up to now, all the components of IceMagic™ CryoAblation system have gained approval, which contributes to the healthiness and wellbeing of AF patients.
Atrial Fibrillation is the most common type of cardiac arrhythmia, affects over twenty million people in China currently. As the innovative therapy in atrial fibrillation treatment—Cryoablation simplifies the radiofrequency ablation and innovates traditional point-by-point radiofrequency ablation for pulmonary vein isolation (PVI） by forming continuous band-like transmural lesions , which brings advantages to clinical applications relating to short operation time, high maneuverability and easy acquisition.
Integrated IceMagic™ CryoAblation Catheter with IceMagic™ CryoAblation Console, by adopting Cryoballoon Ablation (CBA) technology, utilizing intracellular ice crystals produced by cryogenic energy from N2O gasification，to achieve pulmonary vein isolation. These two products have been approved for the treatment of drug-resistant, recurrent, symptomatic and paroxysmal AF.
There are two main types of CryoAblation Catheter: Type A and Type B. Some type A models feature multi-channel surface temperature measurement, while type B feature inner-balloon pressure monitoring and some type B models feature short Tip design. Physicians could choose different types of cryoablation catheter based on their procedures’ demands.
CryoAblation Console is equipped with technologies of multi-parameter signals control and multi-channel temperature sensing, innovatively providing the multi-level target temperature setting function to stabilize the temperature value, which prevents excessive ablation during the procedure and the need to stop ablation manually. In the meantime, integrated with surface temperature monitoring catheter, CryoAblation Console could monitor the changing temperature of balloon surface in real-time, which could be utilized for tissue contact monitoring to enable safe, effective and efficient cryoablation procedures.
In June 2021, IceMagic™ CryoAblation Console passed NMPA’s special review procedures for innovative medical devices, and entered the National Innovation Green Channel in China. The novelty and creativity of the product have been confirmed officially. In June 2022, after one-year follow-up study of participants, the safety, efficacy and clinical application value of IceMagic™ CryoAblation Console were recognized. The approval of IceMagic™ CryoAblation Console marks the official entry of China’s medical devices into the cryoablation market, bringing a new inclusive treatment solution for AF patients in China.
Yiyong Sun, President of MicroPort EP, noted that cryoablation technology for AF treatment has been widely accepted, but domestic-made products portfolio remained vacant until now. The NMPA approval of IceMagic™ CryoAblation products portfolio not only fills in the gap in Chinese cryoablation market, but also accelerates the localization of AF procedures. In the future, MicroPort EP will continue to invest in technology development and products innovation, offering comprehensive solutions for diagnosis and therapy of electrophysiological interventions for physicians and patients worldwide.
