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.

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.