US-based bioelectric medicine company Pulse Biosciences has received the US Food and Drug Administration (FDA) 510(k) approval for its CellFX nsPFA (nanosecond pulsed field ablation) system.
CellFX is a percutaneous electrode system intended for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures.
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The system is designed to deliver nanosecond pulses of electrical energy to non-thermally clear cells, without affecting adjacent noncellular tissue.
It comes with a percutaneous needle electrode, used with CellFX nsPFA Console, to deliver the advantages of nsPFA energy, enabling precise, non-thermal removal of cellular tissue.
The electrode is designed to induce thermal necrosis, without damaging noncellular structures, and is not recommended for non-cardiac applications.
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.
“I couldn’t be more proud of the engineering, clinical and regulatory teams at Pulse Biosciences for their commitment to bringing the safety and effectiveness benefits of nsPFA to our physician, caretaker and patient partners.
“Internally, our team is pleased with its manufacturing and operational readiness as we initiate our training and commercialization programs in the coming weeks.”
Pulse Biosciences said that the CellFX nsPFA percutaneous electrode system represents a promising new minimally invasive non-thermal treatment option for patients.
The system provides physicians with intuitive usability, short procedure times and customisable energy delivery to treat different types of patients needing soft tissue ablation.
The early study results showed that the CellFX nsPFA system resulted in fast clearance of ablated cellular tissue, without any evidence of thermal damage or residual scarring.
In January this year, Pulse Biosciences announced filing a premarket notification 510(k) to the US FDA for its novel CellFX nsPFA Cardiac Clamp.
