MicroPort EP's PulseMagic™ Pulsed Field Ablation System Receives EU CE MDR Certification and Makes European Market Debut

Paris, France - April 12, 2026 — MicroPort EP announced that its PulseMagic™ Pulsed Field Ablation Generator and PulseMagic™ Pulsed Field Ablation Catheters have received CE marking under the EU Medical Device Regulation (MDR). The European market launch of the PulseMagic™ product series took place at the European Heart Rhythm Association Annual Meeting (EHRA 2026) in Paris, France.

Atrial fibrillation is the most common sustained cardiac arrhythmia, associated with significant morbidity and an increased risk of stroke and heart failure. Atrial fibrillation affects 1.5–2% of European adults, with prevalence anticipated to reach 9.5% in individuals aged over 65 by 2060.¹ While catheter ablation remains an established treatment option, pulsed field ablation (PFA) is an emerging energy modality designed to offer tissue-selective ablation with the aim of improving procedural safety and efficacy.

The PulseMagic™ system supports both microsecond and nanosecond dual technology pathways and is available in two catheter configurations:

  • PulseMagic™ Spiral Pulsed Field Ablation Catheter: features a three-dimensional double-loop structure designed to simultaneously cover both the antrum and ostium of the pulmonary vein, intended to widen the ablation zone and support continuity of ablation. The catheter is designed to integrate with the Columbus™ 3D Cardiac Electrophysiological Mapping System, enabling a mapping-modelling-ablation workflow with millimetre-level precision navigation.
  • PulseMagic™ Flower Pulsed Field Ablation Catheter: features a petal-shaped design intended to improve catheter adaptability to complex pulmonary vein anatomies, supporting nanosecond pulsed field ablation.

The PulseMagic™ system is part of MicroPort EP's PRIME integrated electrophysiology platform, an all-in-one suite spanning five complementary technology solutions:

  • P (PF): PulseMagic™: Pulsed Field Ablation
  • R (RF): FireMagic™: Radiofrequency Ablation with contact force monitoring and high-density mapping
  • I (Ice): IceMagic™: Cryoablation with surface temperature monitoring
  • M (Magnet): Magbot™: Robotic Magnetic Navigation
  • E (Echo): EasyEcho™: Intracardiac Echocardiography Imaging

The EasyEcho™ Intracardiac Echocardiography System also made its European debut at EHRA 2026. Its high-definition real-time imaging capabilities and catheter maneuverability drew attention from clinicians across Europe, North America, and various international markets. 

MicroPort EP will continue to advance the global deployment of its integrated electrophysiology platform, with the aim of providing physicians and patients worldwide with comprehensive solutions for the interventional diagnosis and treatment of cardiac arrhythmias.

 

About MicroPort EverPace

Founded in 2010, MicroPort EverPace (Shanghai MicroPort EP MedTech Co., Ltd; SSE: 688351), an associated company of MicroPort® (MicroPort Scientific Corporation; HKEX: 00853), is a global medical device company focusing on the development, manufacturing, and commercialization of minimally invasive medical devices for the treatment of cardiac arrhythmia. It has developed a family of advanced cardiac ablation catheters, diagnostic catheters, and 3D navigation systems. These solutions are used by hundreds of physicians at over 1100 hospitals in more than 30 countries. MicroPort EverPace strives to provide integrated therapeutic solutions that apply precise navigation to interventional procedures, delivering high-quality care to patients and physicians across the globe.

 

References

  1. The Lancet Regional Health — Europe. Atrial Fibrillation Series. 2024. Available at: https://www.thelancet.com/series-do/europe-atrial-fibrillation

 

The PulseMagic™ Pulsed Field Ablation Generator and PulseMagic™ Pulsed Field Ablation Catheters have received CE marking under the EU MDR. Regulatory status varies by country and region. Not all products or indications described in this release may be approved in all markets. Healthcare professionals should refer to applicable local regulatory requirements and instructions for use.