Shanghai, China — On June 8, the IceMagic® Cardiac Cryoablation System, developed by Shanghai MicroPort® EP MedTech Co., Ltd. (MicroPort® EP), was granted access to the ‘Green Path’, a special review process for innovative medical devices by China’s National Medical Products Administration (NMPA). This marks the 21st product from a MicroPort® subsidiary or related company that is eligible for the ‘Green Path’ procedure.
The main treatment options for atrial fibrillation include medication therapy and non-medication therapy. The Green Path-ready IceMagic® Cardiac Cryoablation System applies a number of core invention patents in R&D. It consists of a cryoablation device, cryoballoon catheters, a disposable intracardiac mapping catheter and a steerable introducer set. In May 2020, the system successfully completed the first pre-market clinical trial enrollment, and its effect was fully affirmed by the physician team.
Dr. Yiyong Sun, President of MicroPort® EP, said, “IceMagic® Cardiac cryoablation system for the treatment of atrial fibrillation has been widely used and recognized, but it is still in a foreign monopoly stage, and there has been an absence of such devices in China. We are committed to developing equivalent products with independent intellectual property rights to promote the development and usage of this technology domestically, as a means to support patients and doctors with more affordable solutions. The inclusion of the IceMagic® Cardiac Cryoablation System into the Green Path is a recognition of the R&D and innovative capability of MicroPort® EP.”
Atrial fibrillation is a common type of cardiac arrhythmia that currently affects more than 10 million people in China. However, atrial fibrillation can react poorly to medication therapy, and often recur. Cryoablation is a more recent and innovative technique that achieves pulmonary vein isolation through a process of temperature drop and restoration for treatment purposes. Compared to the traditional point-by-point radiofrequency ablation, cryoablation using balloon type ablation catheter is easier and faster to perform, thus reducing the learning curve of physicians.
The cryoablation balloon catheter can realize the ablation target temperature control when combined with the IceMagic® Cardiac Cryoablation System to meet the multi-strategy cryoablation plan. At the same time, the tissue temperature-measuring balloon can monitor the temperature change of the ablation target and provide more ablation process parameter monitoring. An intracardiac mapping electrode catheter is used to check the electrical signal of the circular pulmonary vein during cryoablation; the steerable introducer set is used to guide the cryoballoon ablation catheter to the target site and provide support to the catheter.
In the future, MicroPort® EP will invest more in research and development to launch more high-quality, affordable, and independently developed products to provide patients and physicians with leading total solutions for medical treatment in the field of electrophysiological interventions.
About MicroPort® EP
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.