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Shenyang,China—The IceMagicTM Cardiac Cryoablation System (“the IceMagicTM system”), independently developed by Shanghai MicroPort EP MedTech Co.,Ltd. (MicroPort EP), was recently used in an atrial fibrillation ablation procedure at the General Hospital of the Northern Theater Command. This very last procedure of the clinical trial of the IceMagicTM system marks the successful completion of subject enrollment since the first procedure was carried out in May 2020. Earlier in June, the IceMagicTM systementered the “Green Path”, a special review process for innovative medicaldevices, after its application was approved by China's National Medical Products Administration (NMPA). The IceMagicTM system is expected to become the first made-in-China cardiac cryoablation system licensed for marketing in China.
The clinical trial of the IceMagicTM system is a prospective,multi-center clinical study led by the General Hospital of the Northern Theater Command and participated by the Tianjin Chest Hospital, the First Hospital of Jilin University, the Second Hospital of Hebei Medical University, the First Hospital Affiliated to the Air Force Military Medical University of the Chinese People's Liberation Army, the Shanxi Cardiovascular Hospital, the Zhoupu Hospital of ShanghaiPudong New Area and the Central Hospital of Shanghai Putuo District, with an aim to evalsuate the safety and efficacy of the IceMagicTM system inatrial fibrillation procedures.
As an emerging technology for the treatment of atrial fibrillation, cryoablation enables rapid electrical isolation of the pulmonary vein by creating a temperature drop and restoration for treatment purposes. Compared with traditional point-by-point radio frequency ablation, cryoablation can achieve comparable safety and efficacy while enables easier procedure and shorter operational time, thus reducing the learning curve of physicians. Made possible by multiple patented core inventions, the IceMagic™ system consists of acryoablation device, cryoballoon catheters, a disposable intracardiac mapping catheter, and a steerable introducer set.
Prof.Zulu Wang from the General Hospital of the Northern Theater Command said, “The home grown cryoballoon catheter developed by MicroPort EP features anumber of innovational benefits, such as a temperature-controlled function thatimproves surgical safety while achieving cryotherapy results. Moreover, thetemperature sensor on the balloon surface allows real-time monitoring of the effectof freezing. I look forward to the development of more and better products from MicroPort EP for the benefit of more patients.”
Prof.Jing Xu from Tianjin Chest Hospital stated that, “The cryoablation equipmentand consumables developed by MicroPort EP have excelled in the clinical trial, and their performance is comparable to those of imported products, Particularly, the flow control function is quite unique. The development of medical technology in China depends on continuous innovation. We expect more innovative products from MicroPort EP to be launched inthe future.”
Dr.Yiyong Sun, President of MicroPort EP extended his gratitude to the expert team for their support and guidance during the product R&D process. “Cryoablation brings a new solution for cardiac electrophysiologists and patients with atrial fibrillation. But unfortunately, made-in-China cryoablation systems are not yet available in China. The completion of this clinical trial has laid the foundation for providing more patients with a more inclusive treatment solution,”said Dr. Sun. “In the future, MicroPort EP will continue to invest more resources in innovation and clinical trials, offering a better total solution for patients and doctors in electrophysiological interventions,” he added.
