The US Food and Drug Administration (FDA) has issued 510(k) clearance for Pulse Biosciences’ CellFX nanosecond pulsed field ablation (nsPFA) percutaneous electrode system. 

The system is designed for the ablation of soft tissue during percutaneous and intraoperative surgical procedures. 

Pulse Biosciences president and CEO Kevin Danahy said: “The FDA clearance of our Percutaneous Electrode System is the initial major milestone for Pulse Biosciences in surgery. It opens a new set of clinical applications and opportunities wherein our proprietary, one-of-a-kind, patented CellFX nsPFA technology is highly differentiated and holds the potential to change the present time standard of care.  

“Internally, our team is pleased with its manufacturing and operational readiness as we initiate our training and commercialization programs in the coming weeks.  

“We look forward to providing additional details and colour on these commercial programs in our upcoming fourth quarter and full year 2023 earnings conference call scheduled for Thursday 28 March 2024.” 

Designed to work with the Pulse Biosciences’ CellFX nsPFA Console, the CellFX nsPFA Percutaneous Electrode System features a percutaneous needle electrode. 

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The electrode, which is intended for non-cardiac applications, can harness and deliver the key benefits of nsPFA energy. This allows accurate, non-thermal removal of cellular tissue without non-cellular structure damage or inducing thermal necrosis.  

Pulse Biosciences scientific advisory board chair and senior adviser and Florida State University College of Medicine clinical professor for surgery Ralph P Tufano said: “The CellFX nsPFA percutaneous electrode system represents a much-needed and promising new minimally invasive non-thermal treatment option for patients. For physicians, the system offers intuitive usability, short procedure times and customisable energy delivery to treat a variety of patients requiring soft tissue ablation.” 

In December 2023, Pulse Biosciences completed the first-in-human procedures using its new CellFX nsPFA cardiac catheter.