Pulse Biosciences (PLSE) announced a new publication in the Journal of Thoracic and Cardiovascular Surgery. This preclinical study demonstrates the advantages of the nano-PFA Cardiac Surgical System over radiofrequency technology for the ablation of cardiac tissue. The study was designed to demonstrate the safety and efficacy of a new nanosecond pulsed field ablation parallel clamp, Pulse Biosciences’ nano-PFA Cardiac Surgical System, in ablating different cardiac tissue locations. Ablations were performed in all four heart chambers of porcine models by delivering a sequence of very short-duration high-amplitude electrical pulses taking 1.25 seconds per application, independent of tissue thickness or type. Results validated the expected clinical benefits of nano-PFA, as all lesions produced by this technology resulted in persistent exit block of pulmonary veins. This is consistent with the histology showing reliable, durable contiguous and transmural ablations without injury to adjacent organs. The company is progressing with a multi-center, first-in-human atrial fibrillation feasibility study in Europe. Currently, three centers in the Netherlands are enrolling patients into the study. The company expects to share preliminary results of the trial in late 2025.
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