Sphere-9 Mapping and Ablation Catheter - Cardiac radio-frequency ablation system catheter

Intended purpose

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