Device Dossier

FARAPOINT Pulsed Field Ablation Catheter - Cardiac irreversible electroporation system catheter

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

Intended purpose

The FARAPOINT Catheter is indicated for the ablation of the cavotricuspid isthmus to treat Typical Atrial Flutter.

Functional description

The FARAPOINT Catheter is a single use device intended for recording intracardiac electrograms, delivering diagnostic pacing stimuli, and creating endocardial lesions when used with a compatible BSC ablation system to deliver pulsed field energy to render targeted cardiac tissue electrically non-conductive.

TGA Public Summary