Device Dossier

Sphere-9 Catheter - Cardiac radio-frequency ablation system catheter

Device Dossier for Sphere-9 Catheter - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency ablation system catheter, Class III,…

Intended purpose

The Sphere-9 catheter is an irrigated single-use catheter intended for cardiac electrophysiology mapping, delivering diagnostic pacing stimuli, and creating endocardial lesions in the atria of the heart when used with a compatible Affera mapping system and Affera ablation system to deliver radiofrequency (RF) or pulsed field (PF) energy.

Functional description

The Sphere-9™ Catheter is a steerable irrigated multi-electrode catheter with a bidirectional deflecting tip designed for intracardiac mapping and ablation.

TGA Public Summary