Pulsecare Medical, a leader in cardiovascular interventional technologies, has announced that its cutting-edge 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 commercially approved third-generation ns-PFA system, NxPFA™ leverages high-voltage nanosecond pulses for pulmonary vein isolation (PVI) in the treatment of atrial fibrillation (AF), marking a pivotal advancement in cardiac electrophysiology and launching the era of PFA 3.0.
Pulsed field ablation (PFA) has transformed atrial fibrillation treatment with its selective tissue targeting, enhanced safety profile, and procedural efficiency. However, earlier-generation systems based on microsecond pulses (μs-PFA) have faced clinical limitations, including significant muscle stimulation, the need for general anesthesia, and procedural risks such as hemolysis and gas embolism.
Pulsecare’s NxPFA™ system stands out as the only commercially available nanosecond PFA solution globally. It integrates the MaviPulse™ high-frequency ns-PFA console with the InteShot™ basket-shaped catheter to deliver precise, irreversible electroporation of cardiac cells. This next-generation system effectively overcomes the limitations of μs-PFA by:
Reducing neuromuscular stimulation, enabling procedures under conscious sedation for improved patient comfort and reduced anesthesia risk;
Enhancing electrode-tissue contact via its basket-shaped catheter design, improving ablation efficiency and shortening procedure time;
Minimizing intravascular gas formation, thereby lowering the risk of stroke and systemic embolism;
Reducing red blood cell damage and bilirubin elevation, helping to protect kidney function.
NxPFA™'s clinical performance has been validated in the multicenter SCENA-AF registration trial, which enrolled 166 patients with paroxysmal atrial fibrillation. The results, which have been reviewed and accepted by the NMPA and are pending publication in a peer-reviewed journal, demonstrate:
100% acute PVI success rate
88.27% one-year treatment success rate (PPS)
Zero device-related serious adverse events
Over 92.8% of procedures completed under conscious sedation, with excellent patient tolerance
These findings confirm NxPFA™’s exceptional efficacy, safety, procedural efficiency, and patient-centered design. It is currently the only PFA system globally capable of delivering successful, one-shot PVI under conscious sedation.
“NxPFA™'s approval is a significant milestone for Pulsecare Medical and a transformative step for the field of electrophysiology,” said Dr. Javen Tan, CEO of Pulsecare Medical. “This system addresses long-standing challenges in AF ablation and reflects our commitment to advancing multimodal cardiovascular therapies. We look forward to working with EP experts worldwide to shape the next generation of arrhythmia care—offering physicians smarter tools and patients safer, more effective, and more comfortable treatments.”