Pulse Biosciences (Nasdaq:PLSE) announced that the FDA granted 510(k) clearance for its CellFX nsPFA percutaneous electrode system.
The Hayward, California-based company develops the CellFX nanosecond pulsed field ablation (nsPFA) system. Its percutaneous electrode system enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures.
CellFX nsPFA’s percutaneous electrode system features a percutaneous needle electrode for use with the proprietary CellFX console. The company designed the novel electrode to harness and deliver the key advantages of nsPFA energy. It enables the precise, nonthermal removal of cellular tissue without damaging noncellular structures or inducing thermal necrosis.
Pulse Biosciences designed this percutaneous electrode for non-cardiac applications, unlike other PFA technology on the market. The likes of Medtronic and Boston Scientific have FDA-cleared PFA systems for cardiac procedures. Biosense Webster also hopes to bring one to the U.S. market, after recently earning European approval.
In a news release, Pulse Biosciences CEO Kevin Danahy called the FDA clearance “the initial major milestone” for the company. He said it “opens a new set of clinical applications” for the “highly differentiated technology” to potentially change the 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,” Danahy said. “Internally, our team is pleased with its manufacturing and operational readiness as we initiate our training and commercialization programs in the coming weeks.”