Pulse Biosciences has filed a premarket notification 510(k) to the US Food and Drug Administration (FDA) for its novel CellFX nanosecond pulsed field ablation (nsPFA) cardiac clamp.
Pursuant to Section 510(k), once the application has been accepted, the FDA will conduct its substantive review and may request additional information from the company based on that review. FDA guidance suggests the goal is to complete 510(k) review within 90 calendar days, not including time required by the company to respond to additional information requests. The time required to respond to any such requests will depend on the nature of the request.
“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 utilising the CellFX nsPFA cardiac clamp for their patients,” said 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.”
Pulse Biosciences’ CellFX nsPFA cardiac clamp is designed to produce continuous linear transmural ablations during concomitant cardiac surgical procedures using the company’s novel CellFX system.
The bipolar clamp utilises the company’s proprietary nsPFA technology, a non-thermal ablation technology, and preclinical data suggest nsPFA may provide safety and performance benefits over the current thermal ablation technologies for cardiac ablation, such as the use of extreme heat or cold.
A single CellFX nsPFA cardiac clamp ablation can be done in one-twentieth of the time of current thermal ablation technologies and, due to the non-thermal mechanism of action, does not have the risk of thermal spread leading to unintended collateral damage to adjacent tissue and structures.
“In my professional opinion, with FDA and worldwide regulatory clearance, the CellFX nsPFA cardiac clamp may become the gold standard in cardiac ablation for cardiothoracic surgeons. The consistency of continuous transmural ablations in a fraction of the time it takes for current radiofrequency or cryothermal ablation devices, combined with the safety benefits of nsPFA’s nonthermal mechanism of action, may well be rapidly adopted by cardiothoracic surgeons like myself that perform cardiac ablations routinely, ” said Gan Dunnington, chief medical officer, cardiac surgery of Pulse Biosciences. “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 chief executive officer of Pulse Biosciences.
