Shanghai MicroPort EP MedTech Co., Ltd. (hereinafter referred to as "MicroPort EP") has recently obtained the CE MDR certification for its self-developed innovative IceMagic™ CryoAblation Catheter. With this certification, all components of IceMagic™ CryoAblation System have now secured CE MDR certification, marking the official entry of its cryoablation products portfolio into the international market.

Atrial fibrillation (AF) is a prevalent clinical cardiac arrhythmia. Cryoablation simplifies the complex process of AF catheter ablation by creating continuous linear transmural lesions, replacing the traditional point-by-point approach of radiofrequency ablation for pulmonary vein isolation. While ensuring safety and efficacy, this technique offers clinical advantages such as shorter procedure time, simpler operation, and a shorter learning curve for physicians.

The certified IceMagic™ CryoAblation System includes the IceMagic™ CryoAblation Console, IceMagic™ CryoAblation Catheter, IceMagic™ EasyLoop™ Circular Mapping Catheter, and PathBuilder™ Advance Steerable Introducer. Notably, IceMagic™ CryoAblation Catheter integrates multiple temperature sensors on its surface, enabling real-time temperature monitoring of tissue contact. IceMagic™ CryoAblation Console features built-in temperature control mode, supporting preset the temperature value to achieve consistent and stable ablation, preventing excessive freezing.

The CE MDR certification will further accelerate the globalization of MicroPort EP's cryoablation products, enhance its brand recognition in overseas markets, and positively impact its global expansion. In the future, MicroPort EP will remain committed to providing more high-quality and innovative products to the global market, providing a comprehensive electrophysiology treatment and diagnostic integrated solution for patients worldwide.