Pulsecare Medical Announces NMPA Approval of NxPFA™, the World’s First Nanosecond PFA System, Ushering in the PFA 3.0 Era

August 4, 2025
8:25 pm

SHENZHEN, China, Aug. 4, 2025 /PRNewswire/ -- Pulsecare Medical, a pioneer in cardiovascular intervention technologies, announced that its innovative NxPFA™ nanosecond pulsed field ablation (ns-PFA) systemhas 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 isolation (PVI) in atrial fibrillation (AF) treatment, this breakthrough marks the dawn of the PFA 3.0 era and represents the innovative capabilities of Pulsecare Medical in cardiovascular multimodal therapy.

PFA has revolutionized AF treatment through its tissue selectivity, safety, and procedural efficiency. Yet, early-generation systems using microsecond pulses face key challenges—excessive muscle stimulation, reliance on general anesthesia, and risks like hemolysis and gas embolism—that limit broad adoption.

As the world’s first and only commercially available nanosecond PFA system, NxPFA™ represents the “Next of PFA” generation. It combines the MaviPulse™ high repetition frequency ns-PFA console with the InteShot™ basket-shaped catheter to deliver irreversible electroporation of cardiomyocytes via high-voltage nanosecond pulses, effectively overcoming key limitations of microsecond PFA (μs-PFA) technologies:

Pulsecare Medical Announces NMPA Approval of NxPFA™, the World’s First Nanosecond PFA System, Ushering in the PFA 3.0 Era

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