December 5, 2022 – Medtronic announced the completion of enrollment and final treatment in the SPHERE Per-AF Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial designed to evaluate the safety and effectiveness of the first-of-its kind Sphere-9™ pulsed field (PF) and radiofrequency (RF) ablation, and high density (HD) mapping catheter with the Affera cardiac mapping and navigation platform for the treatment of persistent atrial fibrillation (AF).
The investigational Medtronic technology includes the Affera mapping/navigation platform, designed to improve efficiencies by enabling intuitive HD mapping to diagnose arrhythmias and treat patients with one catheter. The Sphere-9 catheter combines mapping, navigation, and therapeutic capabilities and is the only catheter capable of delivering both RF and PF energies for ablation, providing physicians with the ability to customize treatment based on a patient’s needs during an ablation procedure.
The SPHERE Per-AF Trial is a global, prospective, multicenter, randomized clinical trial. Since the trial’s commencement in December 2021, the trial enrolled 477 patients with persistent AF across 23 centers in the U.S. and Europe. Patients will be assessed for 12 months for safety and efficacy.