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Shanghai, China—Shanghai MicroPort EP MedTech Co., Ltd (referred to as MicroPort EP) announced European CE mark approval and UKCA approval of FireMagic™ TrueForce™ ablation catheter (referred to as TrueForce™ ablation catheter). It is the first domestic developed and manufactured catheter featuring force-sensing technology to obtain CE mark and UKCA approval.
TrueForce™ ablation catheter is composed of a radiofrequency ablation catheter, a connection cable and a connection box. The catheter encompassing the main body of high torque and a bendable tip. In the meantime, the catheter tip equipped with a platinum-iridium electrode, a tip electrode and 3 ring electrodes. When integrated with Columbus™ 3D EP navigation system and OptimAblate™ cardiac RF generator, they can be utilized for the treatment of drug-resistant, recurrent, symptomatic, and paroxysmal atrial fibrillation.
TrueForce™ ablation catheter combines force-sensing technology based on the theory of strain gage, magnetic-based positioning and multi-holes saline infusion technology, providing real-time measurement of contact force between the catheter tip and heart wall, which can be used for prevention of steam pop resulted from excessive contact force or incomplete ablation resulted from deficient contact force. When utilized in conjunction with Columbus™ 3D EP navigation system, the TrueForce™ ablation catheter provides active measurement of catheter-tissue contact force and force vector, calculating Energy Index (EI) based on key ablation parameters related to lesion formation in real-time, in order to optimize procedures’ efficiency in long-term.
In 2022, TrueForce™ ablation catheter received National Medical Product Administration’s approval in China. Until now, there are more than 400 radiofrequency ablation procedures in China completed by using TrueForce™ ablation catheter. The approval of CE mark and UKCA represents a milestone of MicroPort EP reaching to European markets, British markets and other overseas markets, supporting the further marketing development of MicroPort EP.
In the future, MicroPort EP will continue to invest in technology development and products innovation, offering comprehensive solutions for diagnosis and therapy of electrophysiological interventions for physicians and patients worldwide.
