The trial is evaluating the safety and effectiveness of the Sphere-9. The Sphere-9 is a pulsed field (PF) and radio frequency (RF) ablation and high-density mapping catheter. Along with the Affera cardiac mapping and navigation platform, it treats atrial fibrillation.
Affera designed the technology to diagnose, map and treat heart arrhythmias with ablation. It scars heart tissue to interrupt errant signals using both radiofrequency ablation and non-thermal pulsed-field ablation technology. Medtronic acquired the company for $1 billion in August.