Abstract
The purpose of this study was to demonstrate the safety and performance of the CellFX Percutaneous Electrode for delivering nanosecond pulsed field ablation (nsPFA) energy to soft tissues. Three different porcine tissue types were treated, namely, liver, kidney, and skeletal muscle, at treatment levels of three times greater than clinical treatment levels. The histological characteristics of the ablation zone for each of these tissues compared with that of radiofrequency (RF) ablation on day 0 and 2 days post-treatment. Ablation zone dimensions were measured during gross necropsy after tetrazolium chloride staining and compared between the nsPFA and RF groups at 2 days post-ablation. The CellFX system successfully achieved ablation and necrosis of all treatment sites in all target tissues. No evidence of thermal effects or collagen degeneration was found at any of the nsPFA treatment sites. Overall systemic tolerability was evidenced by the absence of clinically significant changes in urinalysis and serum chemistry before and after treatments.