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FARAPULSE™

Pulsed Field Ablation System*

Selective tissue targeting1

Selective Tissue Targeting
Cardiomyocytes have low thresholds to PFA while other tissue/cell types are more resistant and remained uninjured despite exposure to the field.
The goal of PFA therapy is to isolate and target specific characteristics of cardiac tissue for irreversible electroporation to induce cell death and durable lesions. Unlike thermal methods, PFA is cardiac tissue-selective due to the lower damage threshold for cardiomyocytes. This addresses the risk of collateral injury to adjacent structures.
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*CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale. Product not FDA approved. Not approved for sale in the US. For educational purposes only.
 
 

Irreversible electroporation2

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 the 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. This could be perceived as acute isolation through cardiac stunning without achieving the irreversible electroporation needed for durable lesions.
 
 

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 impact lesion profiles that affect safety and efficacy. PFA is highly parameter dependent so each system must be evaluated independently as the results do not transfer from system to system. Although each system may achieve acute isolation via cardiac stunning (reversible electroporation), results might not transfer to long-term lesion durability (irreversible electroporation).

The FARAPULSE™ PFA System utilizes bipolar, biphasic waveforms with proprietary pulse parameters and dosing strategies and is being studied in the ADVENT Trial to validate its safety and efficacy.
  
  

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
  • The study results emphasized the importance of using remap data to delineate lesion durability with individual PFA systems – demonstrating how one system’s results do not transfer to another system’s results
  • The optimized waveform and applications demonstrated 96% of pulmonary veins isolated at remap
  
 
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