Sphere-360 Pulsed Field Ablation Catheter - Cardiac irreversible electroporation system catheter

Intended purpose

The intended purpose of the Sphere-360 catheter is to perform cardiac electrophysiology (EP) mapping, ablate cardiac tissue using pulsed field (PF) energy, and perform cardiac stimulation during electrophysiology procedures.

Functional description

The Sphere-360 pulsed field ablation catheter is a sterile, single-use, electrophysiology mapping and ablation catheter designed to create a circumferential ablation lesion around a pulmonary vein for the treatment of atrial fibrillation using pulsed field (PF) ablation energy. The catheter is used in conjunction with the Affera™ ablation system and appropriate return electrode pads for ablation. The catheter is fitted with electromagnetic location sensors to enable visualization.