Shengyang, China, 07 July, 2021 — The IceMagic® Cardiac Cryoablation System (the IceMagic® system), 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 procedure marks the successful completion of subject enrolment of the the IceMagic® system clinical trial since the first procedure was carried out in May 2020. Earlier in June 2021, the IceMagic® system entered the ‘Green Path’, a special review process for innovative medical devices, after its application was approved by China’s National Medical Products Administration (NMPA). The IceMagic® system is expected to become the first made-in-China cardiac cryoablation system licensed for marketing in China.
The clinical trial of the IceMagic® system is a prospective, multi-center clinical study led by the General Hospital of the Northern Theater Command. Participating hospitals included the Tianjin Chest Hospital, the First Hospital of Jilin University, the Second Hospital of Hebei Medical University, and the First Hospital Affiliated to the Air Force Military Medical University of the Chinese People’s Liberation Army. The trial aims to evaluate the safety and efficacy of the IceMagic® system in atrial fibrillation procedures.
Prof. Jing Xu from Tianjin Chest Hospital stated that, “The cryoablation equipment and 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, and we expect more innovative products from MicroPort® EP to be launched in the future.”
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 radiofrequency ablation, cryoablation can achieve comparable safety and efficacy whilst enabling an 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 a cryoablation 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 homegrown cryoballoon catheter developed by MicroPort® EP features a number of innovational benefits, such as a temperature-controlled function that improves surgical safety whilste achieving cryotherapy results. Moreover, the temperature sensor on the balloon surface allows real-time monitoring of the effect of freezing. I look forward to the development of more products from MicroPort® EP for the benefit of more patients.”
President of MicroPort® EP, Dr. Yiyong Sun, later extended his gratitude to the expert team for their support and guidance during the product R&D process, stating, “The completion of this clinical trial has laid the foundation for providing more patients with a new inclusive treatment solution.”
About Shanghai MicroPort® EP MedTech Co., Ltd
Shanghai MicroPort EP MedTech Co., Ltd, a subsidiary of MicroPort Scientific Corporation (MicroPort®, stock code: 00853.HK), was established in the Shanghai International Medical Zone on August 31, 2010. Its concentration is on the development, manufacture, and marketing of minimally invasive medical devices for the treatment of electrophysiological diseases, including cardiac ablation catheters, diagnostic catheters, 3D navigation systems, amongst others.