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 Catheter is indicated for: - the isolation of pulmonary veins in the treatment of recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF). - the isolation of pulmonary veins and the posterior wall in the treatment of drug-refractory, symptomatic Persistent Atrial Fibrillation.

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