Medtronic plc's Sphere-360 secured a CE mark – the second catheter in its Affera PFA franchise – as it announced completion of the first cases in its investigational device exemption HORIZON trial for the Sphere-360 in the U.S. The device is indicated for treatment of paroxysmal atrial fibrillation (AF), an intermittent erratic heartbeat that can progress to persistent AF. Atrial fibrillation affects more than 10.5 million people in the U.S. and 60 million globally.