Pulse Biosciences has announced the receipt of breakthrough device designation from the US Food and Drug Administration (FDA) for its CellFX Nanosecond Pulsed Field Ablation (nsPFA) Cardiac Surgery System.
This system is designed for the ablation of cardiac tissue in the treatment of atrial fibrillation (AF).
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The CellFX system, featuring a surgical clamp, aims to create durable, continuous transmural ablation lesions during cardiac surgery.
The bipolar clamp leverages the company’s nano-PFA technology, which has shown in pre-clinical studies to produce consistent transmural ablations in less than two seconds.
Unlike thermal radiofrequency ablation, the technology’s non-thermal mechanism of action eliminates the risk of thermal spread, potentially reducing collateral tissue damage.
Pulse Biosciences president and CEO Burke Barrett said: “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.
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By GlobalData“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 is now set to follow the premarket approval (PMA) pathway for approval from the FDA, rather than the 510(k) route.
The company plans to commercialise the nsPFA Cardiac Surgical System in the US upon FDA PMA approval, to directly market the device’s treatment benefits.
The pivotal clinical trial for the treatment of AF with the CellFX System is expected to begin next year.
Pulse Biosciences will release further details on the study and its implications for regulatory and commercial strategies later in the year.
The CellFX nsPFA technology delivers nanosecond pulses of electrical energy to selectively clear cells without affecting adjacent non-cellular tissue.
Pulse Biosciences is actively developing the technology not only for AF treatment but also for other applications where it could significantly improve patient care and healthcare provider outcomes.
