首页-尊享会AG(中国)有限公司尊享会AG

Shanghai, China—On June 8, the IceMagic^TM Cardiac Cryoablation System, independently developed by Shanghai MicroPort® EP MedTech Co., Ltd. “MicroPort EP”,has been 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.

Atrial fibrillation is acommon type of cardiac arrhythmia that currently affects more than 10 million people in China. The main treatment options for atrial fibrillation include medication therapy and non-medication therapy. However, atrial fibrillation haspoor result by medication and is prone to recurrence. As an innovative technique emerged in recent years for the treatment of atrial fibrillation,cryoablation achieves pulmonary vein isolation through a process of drop and restoration of temperature for treatment purposes. Compared to the traditional point-by-point radio frequency ablation, cryoablation using balloon type ablation catheter is easier and faster to perform, thus reducing the learning curve of physicians that on the basis of comparable safety and efficacy results.

The Green Path-ready “IceMagic^TM Cardiac Cryoablation System”applies a number of core invention patents in R&D. It consists of acryoablation device, cryoballoon catheters, a disposable intracardiac mapping catheter and a steerable introducer set. The cryoablation balloon cathetercan realize the ablation target temperature control when combined with cryoablation system, which can meet themulti-strategy cryoablation plan. At the same time, the tissue temperature measuring balloon can monitor the temperature change of the ablation target, provide more ablation process parameter monitoring; Intracardiac mapping electro decatheter 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 thecatheter. In May 2020, the system successfully completed the firstpre-market clinical trial enrollment, and its effect was fully affirmed by the physician team.

Dr. Yiyong Sun, President of MicroPort EP, said, “ 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 suchdevices in China. We are committed to developing（equivalent） products with independent intellectual property rights to promote the development and usage of this technology domestically, so as to provide patients with atrial fibrillation and doctors with more affordable solutions. The inclusion of the IceMagic^TM Cardiac Cryoablation System into the Green Path is a recognition of the R&D and innovative capability of MicroPort® EP. With this as a new starting point and a source of motivation, 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 a world-class total solution formedical treatment in the field of electro physiological interventions. ”