By Fineline Cube 
Shanghai Microport EP Medtech Co., Ltd (SHA: 688351) announced that its PulseMagic TrueForce Disposable Pressure-Monitoring Cardiac Electrical Pulsed Field Ablation (PFA) Catheter has received approval from the National Medical Products Administration (NMPA).
Regulatory Approval & Innovation Status
| Attribute | Details |
|---|---|
| Product | PulseMagic TrueForce Disposable Pressure-Monitoring PFA Catheter |
| Approval | NMPA marketing approval (China) |
| Green Channel | Awarded innovative device “green channel” status (Nov 2024) |
| First-in-China | First pressure-monitoring PFA catheter with saline irrigation functionality |
| Key Features | Real-time pressure monitoring + operational visualization + non-thermal ablation |
Technology Integration & Clinical Benefits
- Pressure Monitoring: First PFA catheter in China to integrate real‑time pressure sensing, enabling stable tissue contact assessment.
- Saline Irrigation: Enhances safety and efficacy by cooling tissue and optimizing energy delivery.
- 3D Mapping Synergy: Designed for seamless integration with the Columbus Three-Dimensional Cardiac Electrophysiology Mapping System.
- Non-Thermal Ablation: PFA technology provides precise, irreversible electroporation without thermal damage.
- Physician Value: Achieves “more controllable, more consistent, and more accessible” cardiac ablation procedures.
Market Context & Competitive Landscape
| Product Type | Status | Key Differentiator |
|---|---|---|
| PulseMagic TrueForce | NMPA approved | Pressure monitoring + irrigation |
| Conventional PFA catheters | Available (no pressure monitor) | Lack real-time contact feedback |
| RF/thermal ablation | Market standard | Thermal injury risk, longer procedures |
Strategic Outlook & Commercial Implications
- China EP Market: Domestic cardiac electrophysiology market valued at ¥5 billion (≈ US$700 million), growing at 15 % CAGR.
- First‑Mover Advantage: As the only pressure‑monitoring PFA catheter approved, Microport can capture premium pricing and physician preference.
- Revenue Impact: Analysts estimate ¥300‑500 million (US$42‑70 million) peak annual sales within 3 years post‑launch.
- Global Pathway: China approval may support regulatory submissions in Southeast Asia and serve as clinical data for potential CE mark or FDA pathway.
- Platform Expansion: Success of PulseMagic validates Microport’s integrated EP ecosystem (mapping + ablation).
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial launch timelines, market penetration, and revenue projections for the PulseMagic TrueForce catheter. Actual results may differ due to regulatory, competitive, and reimbursement risks.-Fineline Info & Tech