Pulsecare Medical has announced that its innovative NxPFA 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 utilising high-voltage nanosecond pulses for pulmonary vein isolation (PVI) in atrial fibrillation (AF) treatment, this breakthrough marks “the dawn of the PFA 3.0 era”, according to a Pulsecare press release.
The company claims that, while PFA has revolutionised AF treatment through its tissue selectivity, safety and procedural efficiency, early-generation systems using microsecond pulses face key challenges—including excessive muscle stimulation, reliance on general anaesthesia, and risks like haemolysis and gas embolism—that limit broad adoption.
NxPFA combines Pulsecare’s MaviPulse high repetition frequency ns-PFA console with its InteShot basket-shaped catheter to deliver irreversible electroporation of cardiomyocytes via high-voltage nanosecond pulses, effectively overcoming the aforementioned limitations of microsecond PFA technologies.
Key advantages of the NxPFA system include significantly reducing neuromuscular stimulation, enabling procedures under conscious sedation to improve patient comfort and lower anaesthesia 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, lowering the risk of stroke or systemic embolism; and minimising erythrocytic damage and post-procedural bilirubin elevation, reducing potential kidney injury.
According to Pulsecare, NxPFA has been clinically validated through the SCENA-AF multicentre trial, which enrolled 166 paroxysmal AF patients, with the data now acknowledged by the NMPA and set to be published in an academic journal soon. Key outcomes include a 100% acute PVI success rate, 88.27% one-year treatment success rate, no device-related serious adverse events reported, and more than 92.8% of procedures completed under conscious sedation with “excellent intraoperative tolerance”.
“NxPFA’s approval is not only a major milestone for Pulsecare Medical but also a transformative breakthrough for cardiac electrophysiology [EP]. 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,” said Javen Tan, chief executive officer (CEO) of Pulsecare.
