Additionally, in recognition of the critical unmet need for ventricular arrhythmia treatments, the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Sphere-9 catheter for the treatment of ventricular arrhythmias, which provides an expedited regulatory pathway for the technology in this patient population. The Sphere VT pivotal trial to evaluate Sphere-9 for the treatment of VT and support future approval in the US is now enrolling patients.

The Affera Mapping and Ablation System with Sphere-9 Catheter is an all-in-one, dual-energy pulsed field (PF) and radiofrequency (RF) ablation and high-definition mapping catheter for use in cardiac ablation procedures.