Device Dossier

FARAWAVE Pulsed Field Ablation Catheter - Cardiac irreversible electroporation system catheter

Device Dossier for FARAWAVE Pulsed Field Ablation Catheter - Cardiac irreversible electroporation system catheter (Cardiac irreversible electroporation…

Intended purpose

The FARAWAVE Pulsed Field Ablation (PFA) Catheter is indicated for isolation of pulmonary veins for the treatment of drug refractory paroxysmal atrial fibrillation (PAF).

Functional description

The FARAWAVE Pulsed Field Catheter delivers a customized, controlled form of energy in the form of a therapeutic electric field generated by multiple brief DC voltage pulses across multiple sets of electrodes of the FARAWAVE catheter. This modality, also referred to as irreversible electroporation, selectively ablates cardiac tissue to render it electrically inactive while sparing collateral non-cardiac tissue

TGA Public Summary