Evaluation of the CellFX® Nano-Pulsed Field Ablation (PFA) 360 Catheter Endocardial Ablation System for the Treatment of Atrial Fibrillation

The CellFX nano-PFA 360 Endocardial Ablation Catheter System includes the nano-pFA 360 Endocardial Ablation Catheter, CellFX Console, switcher box/adapter, and sensing cable. The System is a proprietary endocardial catheter system designed for use in cardiac electrophysiology procedures for the treatment of arrhythmias, including atrial fibrillation. The nano-PFA 360 Catheter ablates cardiac tissue using nonthermal nano-second pulses of electrical energy. Nanosecond Pulsed Field Ablation (nsPFA or nano-PFA) is a cell-specific, nonthermal ablation technology that delivers nanosecond-duration pulses of high-amplitude electrical energy to tissue via bipolar electrodes. The pulses disrupt the ability of the cell and internal organelles to maintain cellular homeostasis by creating nanopores in lipid membranes, ultimately leading to regulated cell death (RCD).