Sean Fenske, Editor-in-Chief03.11.24
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CellFX nsPFA Percutaneous Electrode System from Pulse Biosciences. The system is used for the ablation of soft tissue in percutaneous and intraoperative surgical procedures.
The system includes a percutaneous needle electrode used in conjunction with the console. The electrode enables the nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. The system is designed for non-cardiac applications.
“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,” said Kevin Danahy, president and chief executive officer of Pulse Biosciences. “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 color on these commercial programs in our upcoming fourth quarter and full year 2023 earnings conference call scheduled for Thursday, March 28, 2024.”
“The CellFX nsPFA Percutaneous Electrode System represents a much needed and promising new minimally invasive nonthermal treatment option for patients. For physicians, the system offers intuitive usability, short procedure times and customizable energy delivery to treat a variety of patients requiring soft tissue ablation,” said Dr. Ralph P. Tufano, the company’s senior advisor and scientific advisory board chair, Head and Neck Surgery, clinical professor of Surgery at the Florida State University College of Medicine and medical director, Head and Endocrine Surgery for the Sarasota Memorial Health Care System in Sarasota, Fla. “I am extremely encouraged by the early study results by my colleague, Professor Stefano Spiezia, demonstrating the rapid clearance of ablated cellular tissue and absence of any evidence of thermal damage or residual scarring.”
The system includes a percutaneous needle electrode used in conjunction with the console. The electrode enables the nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. The system is designed for non-cardiac applications.
“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,” said Kevin Danahy, president and chief executive officer of Pulse Biosciences. “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 color on these commercial programs in our upcoming fourth quarter and full year 2023 earnings conference call scheduled for Thursday, March 28, 2024.”
“The CellFX nsPFA Percutaneous Electrode System represents a much needed and promising new minimally invasive nonthermal treatment option for patients. For physicians, the system offers intuitive usability, short procedure times and customizable energy delivery to treat a variety of patients requiring soft tissue ablation,” said Dr. Ralph P. Tufano, the company’s senior advisor and scientific advisory board chair, Head and Neck Surgery, clinical professor of Surgery at the Florida State University College of Medicine and medical director, Head and Endocrine Surgery for the Sarasota Memorial Health Care System in Sarasota, Fla. “I am extremely encouraged by the early study results by my colleague, Professor Stefano Spiezia, demonstrating the rapid clearance of ablated cellular tissue and absence of any evidence of thermal damage or residual scarring.”