--A Case Study of MicroPort EP FireMagic TrueForce Pressure Sensing Catheter

In the field of cardiac electrophysiology, radiofrequency ablation serves as a fundamental technique for curing tachyarrhythmias such as atrial fibrillation and supraventricular tachycardia. As the ultimate carrier for energy delivery, the performance of ablation catheters directly determines surgical outcomes. For a long time, pressure-sensing catheter technology, which enables real-time monitoring of contact force between catheter tip and endocardial tissue, was monopolized by overseas manufacturers.

Developed independently by Shanghai MicroPort EP MedTech Co., Ltd., the disposable magnetically navigated radiofrequency ablation catheter with pressure monitoring, namely FireMagic TrueForce, obtained NMPA marketing approval in 2022. It marks a groundbreaking domestic breakthrough in this high-barrier sector and carries milestone significance.

1. Manufacturer: Leading Player in Domestic Cardiac Electrophysiology

Shanghai MicroPort EP MedTech is a subsidiary of MicroPort Scientific Corporation, specializing in the research, production and sales of interventional diagnostic and therapeutic devices for cardiac electrophysiology.

The company delivers comprehensive solutions covering three-dimensional mapping, radiofrequency ablation, cryoablation and pulsed field ablation (PFA). Its core platform, the Columbus 3D Cardiac Electrophysiology Mapping System, is China's first domestically developed system adopting magnetic-electric dual localization. Having been applied in over 50,000 procedures, it provides solid navigational support for clinical adoption of high-end catheters including TrueForce.

2. Technological Breakthrough: Realization and Clinical Value of Pressure Sensing

Traditional non-pressure catheters rely solely on surgeons' manual perception and clinical experience to judge tissue contact status, featuring strong subjectivity and poor stability. Insufficient contact leads to inadequate energy delivery, resulting in surgical failure or disease recurrence. Excessive contact force may raise risks of cardiac perforation. The core innovation of TrueForce lies in the integrated high-precision pressure sensor.

• Real-time pressure monitoring and visualizationMiniature sensors at the catheter tip accurately capture the magnitude and vector direction of contact force in real time. Relevant data is displayed numerically and three-dimensionally on the Columbus system screen, transforming experience-based ablation into data-driven treatment.
• Enhanced ablation accuracy and procedural safetySurgeons conduct ablation under optimal contact force based on real-time feedback, creating effective transmural lesions and boosting surgical success rates. The system also triggers alerts against excessive pressure to avoid myocardial damage.
• Intelligent quantification and postoperative reviewParameters including contact force, ablation duration, temperature and impedance are automatically recorded to generate ablation indexes such as PFEI. It offers quantitative reference for intraoperative decision-making, facilitates postoperative efficacy evaluation and academic review, and promotes standardized electrophysiological procedures.

3. Clinical Validation and International Recognition

Pre-market clinical trials were jointly completed by five top tertiary hospitals nationwide, with relevant findings published in the international journal Pacing and Clinical Electrophysiology. Clinical data proved its pressure detection performance comparable to imported counterparts.

The catheter has been widely adopted domestically and abroad. More than 300 clinical cases were completed by July 2023, gaining positive feedback from over 100 physicians. In 2023, the product acquired CE marking and UKCA certification, and accomplished its first overseas clinical application in Turkey, officially entering the global market.

4. Industrial Impact and Future Prospects

The launch of TrueForce breaks the technological monopoly held by international giants in pressure-sensing catheters, cuts down costs of high-end electrophysiological surgeries, and enables more Chinese arrhythmia patients to access domestically manufactured devices reaching global advanced standards. Beyond individual product advancement, it demonstrates domestic enterprises' capability to pioneer cutting-edge technologies and achieve system-level innovation.

MicroPort EP continues technological iteration and extends pressure sensing technology to emerging pulsed field ablation, launching the PulseMagic TrueForce pressure-monitoring pulsed ablation catheter. Precise contact control is applied to non-thermal ablation, reflecting outstanding technological scalability.

From 3D mapping systems to pressure-sensing radiofrequency and pulsed ablation catheters, MicroPort EP is building an independent full-cycle solution integrating electrophysiology mapping, radiofrequency ablation and cryoablation. It propels China's cardiac electrophysiology intervention into a new era of precision and intelligence.