Pulsecare Medical's NxPFA™ Receives NMPA Approval as World's First Nanosecond Pulsed Field Ablation System
核心洞察
Pulsecare Medical (搜索)'s NxPFA™ (搜索) system has received marketing approval from China's NMPA, becoming the world's first commercially available nanosecond pulsed field ablation system for atrial fibrillation (搜索) treatment.
The SCENA-AF multicenter trial demonstrated 100% acute pulmonary vein (搜索) isolation success rate and 88.27% one-year treatment success rate with no device-related serious adverse events.
The nanosecond technology significantly reduces neuromuscular stimulation, enabling over 92.8% of procedures to be completed under conscious sedation rather than general anesthesia.
Pulsecare Medical (搜索) announced that its innovative NxPFA™ (搜索) nanosecond pulsed field ablation (ns-PFA) system has received marketing approval from China's National Medical Products Administration (NMPA). As the world's first third-generation ns-PFA system utilizing high-voltage nanosecond pulses for pulmonary vein (搜索) isolation (PVI) in atrial fibrillation (搜索) (AF) treatment, this approval marks the dawn of the PFA 3.0 era.
Revolutionary Nanosecond Technology Addresses Key Clinical Challenges
The NxPFA™ (搜索) system represents a significant advancement over early-generation pulsed field ablation systems that use microsecond pulses. While PFA has revolutionized AF treatment through its tissue selectivity, safety, and procedural efficiency, microsecond-based systems face key challenges including excessive muscle stimulation, reliance on general anesthesia, and risks like hemolysis and gas embolism that limit broad adoption.
The NxPFA™ (搜索) system combines the MaviPulse™ high repetition frequency ns-PFA console with the InteShot™ basket-shaped catheter to deliver irreversible electroporation of cardiomyocytes (搜索) via high-voltage nanosecond pulses. This approach effectively overcomes key limitations of microsecond PFA (μs-PFA) technologies by:
- Significantly reducing neuromuscular stimulation, enabling procedures under conscious sedation while improving patient comfort and lowering anesthesia risks
- Combining nanosecond pulses with a basket-shaped catheter to ensure optimal electrode-tissue contact and high success rates while shortening procedural time
- Substantially lowering intravascular gas formation, reducing the risk of stroke or systemic embolism
- Minimizing erythrocytic damage and post-procedural bilirubin elevation, reducing potential kidney injury
Clinical Trial Results Demonstrate Superior Outcomes
The NxPFA™ (搜索) system has been clinically validated through the SCENA-AF multicenter registration trial, which enrolled 166 patients with paroxysmal atrial fibrillation (搜索). The data has been acknowledged by NMPA and will soon be published in an academic journal. Key outcomes from the trial include:
- 100% acute pulmonary vein isolation success rate
- 88.27% one-year treatment success rate (PPS)
- No device-related serious adverse events reported
- Over 92.8% of procedures completed under conscious sedation, with excellent intraoperative tolerance
These results confirm NxPFA™ (搜索)'s strong performance in efficacy, safety, efficiency, and patient comfort. The system remains the only PFA system globally to achieve one-shot PVI under conscious sedation with high success rates.
Industry Impact and Future Outlook
"NxPFA™ (搜索)'s approval is not only a major milestone for Pulsecare Medical (搜索) but also a transformative breakthrough for cardiac electrophysiology," said Dr. Javen Tan, CEO of Pulsecare Medical. "With NxPFA™, we address critical clinical challenges and look forward to collaborating with global EP experts to shape the future of arrhythmia treatment—delivering smarter tools to physicians and safer, more effective, more comfortable therapies to patients."
Founded in July 2021 and headquartered in Shenzhen, Pulsecare Medical (搜索) is dedicated to the innovation and development of cardiovascular multimodal therapeutic devices. The company is building a next-generation energy platform for interventional therapies, offering total solutions for cardiac electrophysiology and hypertension interventional therapy.