Medtronic affera™ mapping and ablation system with sphere-9™ catheter achieves endpoints for safety and efficacy, providing promising evidence for the future of atrial fibrillation treatment

Hrs late breaking data: sphere per-af trial demonstrates novel all-in-one system delivers exceptional results, plus increased efficiency and improved quality of life dublin and boston, may 17, 2024 /prnewswire/ -- medtronic plc (nyse: mdt), a global leader in healthcare technology, today announced positive results demonstrating excellent safety and efficacy of the affera™ mapping and ablation system with sphere-9™ catheter, an all-in-one pulsed field (pf) and radiofrequency (rf) ablation and high density (hd) mapping catheter for the treatment of persistent atrial fibrillation (afib). the sphere per-af study, a u.s. food and drug administration (fda) investigational device exemption (ide) pivotal trial, compared sphere-9 to the conventional thermocool smarttouch® sf radiofrequency ablation catheter with the carto™ 3 system.
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