Pulse Biosciences Files 510(k) for CellFX nsPFA Cardiac Clamp

Pulse Biosciences has filed for a premarket notification 510(k) to the FDA for its novel CellFX nsPFA Cardiac Clamp. Once the application is accepted the FDA will conduct a substantive review. The 510(k) review is suggested to be completed within 90 calendar days.
 
CellFX nsPFA Cardiac Clamp is designed to produce linear transmural ablations during concomitant cardiac surgical procedures using the Company’s nsPFA nonthermal ablation technology. Preclinical data suggests safety and performance benefits over current thermal ablation technologies for cardiac ablation. 
 
A single CellFX nsPFA Cardiac Clamp can be done in one twentieth of the time of current thermal ablation technologies. With the nonthermal mechanism of action, CellFX nsPFA does not have the risk of thermal spread leading to unintended collateral damage to adjacent structures and tissues. 
 
“The comparative preclinical data included in this 510(k) submission clearly demonstrates the highly differentiated safety and performance benefits of nsPFA in cardiac ablation and its potential benefit to patients and physicians. The speed and precision of delivery and the quality of the lesions, independent of tissue type or thickness, along with the impressive safety profile are unique, and I expect will drive many cardiac surgeons like me to start utilizing the CellFX nsPFA Cardiac Clamp for their patients,” said Dr. Niv Ad, Chief Science Officer, Cardiac Surgery of Pulse Biosciences. “We look forward to sharing the preclinical dataset in upcoming scientific meetings and to collaborating with the FDA throughout its review process as we advance the clamp towards clinical use.”
 
Dr. Gan Dunnington, Chief Medical Officer, Cardiac Surgery of Pulse Biosciences told the press, “the CellFX nsPFA Cardiac Clamp is designed to seamlessly replace current radiofrequency ablation devices, and based on the promising preclinical data we have in hand, we believe CellFX nsPFA has the potential to both expand adoption and increase procedure effectiveness, procedure volume and significant clinical use.”
 
“We are beyond excited to start 2024 with another milestone in the Company’s progress into the cardiac market. We expect the CellFX nsPFA Cardiac Clamp will demonstrate the superior safety and effectiveness of nsPFA for cardiac ablation in cardiac surgery and will serve as an entry point into this large and growing market. Along with our CellFX nsPFA 360 Cardiac Catheter, we plan to surround cardiac care teams with next generation nsPFA technology to drive better patient outcomes,” said Kevin Danahy, President and CEO of Pulse Biosciences.