Pulse Biosciences announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its CellFX nsPFA Percutaneous Electrode System.
The CellFX nsPFA Percutaneous Electrode System for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures.
“The FDA clearance of our Percutaneous Electrode System is the initial major milestone for Pulse Biosciences in surgery,” said Kevin Danahy, president and chief executive officer of Pulse Biosciences. “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.”
The CellFX nsPFA Percutaneous Electrode System consists of a percutaneous needle electrode for use with the company’s proprietary CellFX nsPFA Console. The novel electrode is designed to harness and deliver the key advantages of nsPFA energy, enabling precise, nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. This percutaneous electrode is designed for non-cardiac applications.
“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. “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.”
