Medtronic completes enrollment in pivotal trial evaluating first-of-its-kind pulsed field ablation catheter for patients with atrial fibrillation

Sphere per-af will determine the safety and effectiveness of the sphere-9 cardiac ablation and mapping catheter with the affera mapping and navigation system dublin , dec. 5, 2022 /prnewswire/ -- medtronic (nyse:mdt) today 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.
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