Pulsecare Medical announced that Chinese regulatory authorities granted marketing approval for its pulsed field ablation technology.
Shenzhen, China–based Pulsecare develops the NxPFA nanosecond PFA system. It utilizes high-voltage nanosecond pulses for pulmonary vein isolation (PVI) in AFib treatment. The company says its technology marks the world’s first commercially approved nanosecond PFA platform.
Pulsecare hasn’t been the only company that’s been developing nanosecond PFA. For example, Pulse Biosciences is developing nsPFA technology not only for cardiac ablation to treat AFib, but also to ablate benign thyroid nodules.
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According to a Pulsecare news release, early-generation PFA systems use microsecond pulses. However, the company says that present challenges, such as excessive muscle stimulation, reliance on general anesthesia, and risks like hemolysis and gas embolism, limit broad adoption.
Pulsecare’s NxPFA system combines the MaviPulse high-repetition frequency ns-PFA console with the InteShot basket-shaped catheter. Together, they deliver irreversible electrocorporation of cardiomyocytes via high-voltage nanosecond pulses. The company says this enables the system to overcome key limitations of the microsecond PFA technologies.
According to Pulsecare, its system reduces neuromuscular stimulation, enabling procedures under conscious sedation. This improves patient comfort and lowers anesthesia risks. The system lowers intravascular gas formation to lower the risk of stroke or systemic embolism. Meanwhile, it minimizes erythrocytic damage and post-procedural bilirubin elevation to reduce potential kidney injury.
A study of 166 patients with paroxysmal AFib showed a 100% acute PVI success rate and an 88.27% one-year treatment success rate. Pulsecare also reports no device-related serious adverse events.
“NxPFA’s approval is not only a major milestone for Pulsecare Medical but also a transformative breakthrough for cardiac electrophysiology. 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 Dr. Javen Tan, CEO of Pulsecare Medical.
