Pulse Biosciences has received approval from the US Food and Drug Administration (FDA) for its investigational device exemption (IDE) to commence the study of the nanosecond pulsed field ablation (nsPFA) cardiac surgery system to treat atrial fibrillation (AF).
Known as NANOCLAMP AF, this study will assess the effectiveness of the nsPFA cardiac surgical system during concurrent surgical procedures.
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It is a single-arm, prospective trial that plans to involve up to 136 patients across as many as 20 sites, including two international locations.
The nsPFA cardiac clamp is engineered to provide continuous, linear, transmural ablations during cardiac surgeries.
This bipolar device utilises Pulse Biosciences’ non-thermal nsPFA technology, which preliminary clinical findings suggest may present safety and performance benefits compared to conventional thermal ablation techniques.
The non-thermal nature of nsPFA energy is designed to reduce the likelihood of collateral tissue damage.
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By GlobalDataPulse Biosciences co-chairman and CEO Paul LaViolette said: “The study approval is a testament to the quality of the preclinical and human clinical data that has been generated in support of this breakthrough technology.
“Pulse Biosciences is the first company to advance PFA into the cardiac surgical field for the treatment of AF.”
In July 2024, the nsPFA system was granted FDA breakthrough device designation and is currently part of the agency’s Total Product Life Cycle (TPLC) Advisory Programme (TAP).
A first-in-human feasibility study has been ongoing in the European Union since August 2024, with more than 40 patients treated across three sites in the Netherlands.
Surgeons have noted rapid ablation times, with some procedures completed in as little as 2.5 seconds, resulting in consistent, contiguous, and fully transmural lesions, according to the company.
The company anticipates expanding this study with additional sites throughout this year.
It is preparing to present findings related to its nsPFA cardiac clamp at the upcoming annual meeting of the European Association for Cardio-Thoracic Surgery, scheduled to be held between 8 and 11 October 2025 in Copenhagen, Denmark.
