The CellFX Percutaneous Electrode System for Nanosecond Pulsed Field Ablation

Area of Science:

• Biomedical Engineering
• Surgical Technology
• Electrophysiology

Background:

• Pulsed field ablation (PFA) is an emerging modality for tissue ablation.
• Nanosecond pulsed field ablation (nsPFA) offers a novel approach to energy delivery for ablation.
• Evaluating the safety and efficacy of new ablation technologies is crucial for clinical translation.

Purpose of the Study:

• To assess the safety and performance of the CellFX Percutaneous Electrode for nsPFA in soft tissues.
• To compare the histological effects of nsPFA with radiofrequency (RF) ablation.
• To evaluate systemic tolerability of nsPFA treatment.

Main Methods:

• Porcine liver, kidney, and skeletal muscle were treated with nsPFA at supratherapeutic levels.
• Histological analysis of ablation zones was performed at 0 and 2 days post-treatment.
• Ablation dimensions were measured, and systemic effects were monitored via urinalysis and serum chemistry.

Main Results:

• The CellFX system successfully induced ablation and necrosis in all tested tissues.
• No thermal effects or collagen degeneration were observed at nsPFA treatment sites.
• No clinically significant systemic changes were detected, indicating good tolerability.

Conclusions:

• The CellFX system demonstrates promising safety and performance for nsPFA in soft tissues.
• nsPFA shows a favorable non-thermal ablation profile compared to RF ablation.
• Further investigation is warranted for clinical applications of nsPFA technology.