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Tissue Radiologic and Pathologic Response to Biphasic Pulsed Electric Field Technology in a Porcine Model.

Rosa Kaviani1, Robert E Neal1, David W Hunter1

  • 1Galvanize Therapeutics, Redwood City, California.

Journal of Vascular and Interventional Radiology : JVIR
|August 28, 2024
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Pulsed electric field (PEF) ablation demonstrated safety and predictability in a porcine model, with ablation zones showing resolution over time. This offers a promising alternative to thermal ablation, especially near critical structures.

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Area of Science:

  • Biomedical Engineering
  • Medical Devices
  • Surgical Innovation

Background:

  • Thermal ablation techniques are widely used for tissue destruction but can cause collateral damage.
  • Novel non-thermal ablation methods are being explored to improve safety and efficacy.
  • Pulsed electric field (PEF) ablation is an emerging technology with potential advantages.

Purpose of the Study:

  • To assess the safety and radiologic characteristics of a commercial pulsed electric field (PEF) ablation system.
  • To evaluate the tissue response and pathological changes following PEF ablation in a porcine model.
  • To compare PEF ablation with existing thermal ablation modalities.

Main Methods:

  • Monopolar biphasic PEF ablation was performed on liver, kidney, and muscle tissue in a porcine model using the Aliya System.
  • Percutaneous and open approaches were utilized, with animals evaluated on Day 3 and Day 28 post-ablation.
  • Imaging (cone-beam CT, weekly CT), blood serology, gross pathology, and histopathology were used to characterize ablation zones and tissue response.

Main Results:

  • No adverse events or electrocardiographic abnormalities were observed; serologic values normalized by Day 28.
  • Ablation zones were visible on CT, generally decreasing in size over time, with some resolving completely by Day 28.
  • Liver and muscle ablation zones decreased in diameter (20% and 26%), while kidney sites increased (22%); all sites remained focal without collateral damage.

Conclusions:

  • The evaluated biphasic PEF system demonstrated a safe and predictable ablation profile in a porcine model.
  • PEF ablation showed preservation of surrounding structural tissues, suggesting a reduced risk of collateral damage.
  • This technology presents a viable alternative to thermal ablation, particularly for treatments near critical anatomical structures.