The CellFX nanosecond pulsed field ablation (nsPFA) system’s percutaneous electrode system enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures. It received FDA clearance for the ablation of soft tissue in March.
CellFX nsPFA’s percutaneous electrode system features a percutaneous needle electrode for use with the proprietary CellFX console. Pulse Biosciences designed its electrode to harness and deliver the key advantages of nsPFA energy. It enables precise, nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. The company designed it for non-cardiac applications.
The company reported thyroid nodule soft tissue ablation procedures for 30 patients in Italy from April 2023 to January 2024. Dr. Ralph P. Tufano of the Sarasota Memorial Health Care System in Sarasota, Florida, performed the first U.S. case. It took place at Sarasota Memorial’s Thyroid and Parathyroid Center. The patient was treated for a large, symptomatic, benign, thyroid nodule in the office. The procedure included local anesthesia without the need for general anesthesia.
“Treating our first patient under our newly FDA-cleared nsPFA percutaneous system is a fundamental and opportune milestone for Pulse Biosciences,” said Mitch Levinson, chief strategy officer of Pulse Biosciences. “We are all looking forward to evolving the standard of medicine as together we optimize and introduce the CellFX nsPFA percutaneous procedure on a controlled and measured basis through the balance of 2024.”
