FARAPULSE™

Pulsed Field Ablation System

Irreversible Electroporation1

Irreversible Electroporation

The mechanism of action for pulsed field ablation is irreversible electroporation (IRE). Unlike thermal ablation that causes cell death by local tissue temperature, pulsed field ablation applies ultra-rapid electrical pulses above a tissue cell’s specific electrical threshold, destabilizing the cell membrane and forming nanoscale pores that cause the cell’s contents to exit resulting in cell death.

Reversible electroporation can occur if pores are not large enough to cause permanent cell death, which could show immediate loss of intracardiac electrograms perceived as acute isolation through cardiac stunning without achieving the irreversible electroporation needed for durable lesions.

 

Selective Tissue Targeting2

Selective Tissue Targeting
Cardiomyocytes have low thresholds to PFA while other tissue/cell types are more resistant & remained uninjured despite exposure to the field.
FARAPULSE PFA uses a proprietary waveform to isolate and target specific characteristics of cardiac tissue for irreversible electroporation and to induce cell death. Unlike thermal methods, FARAPULSE PFA is cardiac tissue-selective since cardiomyocytes have a lower threshold for damage, which addresses the risk of collateral injury to adjacent structures.
 

PFA is Highly Parameter Dependent3

PFA is Highly Parameter Dependent

PFA exhibits multiple parameters that can be fine-tuned, such as system polarity, waveform shape, catheter design, pulse characteristics and applications. These parameters can result in different lesion profiles and efficacy. Due to each system being different, and PFA being highly parameter dependent – each system must be evaluated independently as the results do not translate from system to system.

Each system may achieve acute isolation via cardiac stunning (reversible electroporation), but results might not translate to long-term lesion durability (irreversible electroporation). The FARAPULSE PFA solution of bipolar, biphasic with proprietary pulses and application sequence was validated through pre-clinical and clinical feasibility studies to support usage.

 

Acute Isolation Does Not Equal Durable Lesions; Remapping Data Validates Dose4

Acute Isolation Does Not Equal Durable Lesions; Remapping Data Validates Recipe

In three multi-center studies enrolling 121 patients to assess durable PVI utilizing PFA via ~2- to 3-month invasive remap, with 110 of 121 patients in the study returning for a remap, all achieved 100% acute PVI. Therapeutic delivery evolved from monophasic, to biphasic, to an optimized biphasic waveform. The cohorts had optimization to pulse parameters and to number of applications per vein, spline shape and number of rotations between ablations. 

  • All PFA provided 100% acute isolation – but results varied drastically by cohorts – demonstrating that acute isolation does not equal durable isolation highlighting one of the deceptive parts of PFA and reversible vs. irreversible electroporation.
  • The study results emphasize the importance of using remap data to delineate true ablation efficacy with individual PFA Systems and why one system’s results do not translate to another system’s results. Even early variations within the same system had different results fine-tuning to the final optimization of waveform and applications.
  • The optimized waveform and applications demonstrated high efficacy rates of 96% of the veins isolated and 84% of the patients treated at remap.
 
 

Interested in learning more?

Coming soon to EDUCARE a learning curriculum to understand FARAPULSE PFA, clinical evidence and workflow for pulmonary vein isolation.

 

 

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