Pulse Biosciences has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its CellFX nanosecond pulsed field ablation (nsPFA) cardiac surgery system.
The cardiac surgery system uses Pulse Biosciences’ proprietary nsPFA technology to ablate cardiac tissue to treat atrial fibrillation (AF).
CellFX nsPFA’s technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while preserving adjacent noncellular tissue.
The CellFX cardiac surgery system, which features a bipolar surgical clamp, is engineered to generate durable, continuous transmural ablation lesions during cardiac surgeries.
According to pre-clinical studies, a single application of less than two seconds with the surgical clamp consistently creates transmural ablation, which is faster than the existing thermal ablation technologies.
Additionally, due to the non-thermal nature of nano-PFA’s mechanism, there are no chances of any thermal spread that can damage collateral tissues.
Pulse Biosciences intends to seek FDA approval through the premarket approval (PMA) pathway rather than the 510(k) route.
Upon PMA approval, the bioelectric medicine company intends to market the nsPFA cardiac surgical system in the US for treating atrial fibrillation.
The approval will also allow direct marketing of the device’s treatment benefits under a specific indication.
Pulse Biosciences president and CEO Burke Barrett said: “The Breakthrough Device Designation granted by the FDA is an exciting milestone for Pulse. It emphasises the unique potential benefits of nanosecond PFA.
“We plan to fully leverage the benefits of this designation and have chosen to seek PMA approval to achieve a specific indication for the treatment of atrial fibrillation.
“We look forward to aligning with the FDA on a pivotal clinical trial design in the near-term and towards initiating our planned first-in-human cases in the Netherlands soon.”
Pulse Biosciences plans to initiate its clinical trial for atrial fibrillation in 2025.
