Pulsed Field Ablation System*
Selective tissue targeting1
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
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
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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