Recently, several high-end electrophysiology interventional products developed by Shanghai MicroPort EP MedTech Co., Ltd. (hereinafter referred to as "MicroPort EP") have successfully obtained EU MDR certification, further advancing the internationalization of domestic medical devices.

The certified products include the FireMagic™ Magbot™ Ablation Catheter, EasyStars™ Magbot™ High Density Mapping Catheter, and EasyStars™ High Density Mapping Catheter, providing more precise and efficient minimally invasive solutions for the diagnosis and treatment of complex arrhythmias.

The FireMagic™ Magbot™ Ablation Catheter and EasyStars™ Magbot™ Hign Density Mapping Catheter are embedded with sensors and multiple magnetic modules. When used with the Genesis RMN® System, their unique feature lies in utilizing the low-intensity magnetic field generated by the system to control the magnetically driven navigation catheter inside the patient’s body, enabling flexible access to any location within the cardiac chamber and achieving precise navigation of the catheter tip. When used with the Columbus™ 3D EP Navigation System, the catheter’s built-in magnetic sensors display its real-time position and complete 3D cardiac modeling. Physicians can then record electrophysiological information and locate lesions on the precise model, enabling accurate diagnosis and treatment of arrhythmias.

Magnetic Drive Navigation Technology offers higher catheter control stability and more accurate positioning, providing a more efficient and safe solution for treating complex arrhythmias. Compared to traditional procedures, this technology significantly reduces the risk of recurrence, making it particularly suitable for complex anatomical structures and high-risk patient groups.

The EasyStars™ High Density Mapping Catheter is available in two configurations: five-branch and eight-branch, both supporting multi-electrode anatomy 3D modeling and high density mapping. Compared to traditional mapping catheters, it further shortens modeling and mapping time while simultaneously acquiring more detailed electrophysiological information with higher ECG signal recognition accuracy. It can be used with 3D mapping system to create 3D cardiac models, providing three-dimensional coordinates of cardiac anatomy and mapping positions, accurately displaying the catheter distal position and direction in real time.

High-Density Mapping Technology relies on multi-electrode mapping catheters to synchronously collect a large number of high-precision electrophysiological signals. While constructing detailed 3D anatomical models of the heart, it rapidly maps intracardiac electrical signals and clarifies arrhythmia mechanisms, providing critical guidance for ablation strategy.

Obtaining EU MDR certification not only facilitates the company’s entry into the European market and expands overseas revenue with high-value-added products but also enhances its overseas "Mapping + Ablation" technology portfolio. By integrating with existing 3D mapping systems, it forms a complete solution, strengthens the technological barrier in full-energy ablation, and improves customer loyalty through precise, efficient, and safe product features. This solidifies the global brand recognition and lays a solid foundation for the rapid expansion of products overseas.

In the future, MicroPort EP will continue to invest in technological research, development, and product innovation, providing physicians and patients with more comprehensive diagnostic and therapeutic products and professional services. The company aims to offer a globally competitive integrated electrophysiology interventional diagnosis and treatment platform.