A new paradigm in electrophysiology: medtronic receives fda approval of affera™ mapping and ablation system and sphere-9™ catheter

First-of-its-kind, all-in-one hd-mapping and dual energy (pulsed field and radiofrequency) ablation catheter highly anticipated by electrophysiologists for its innovation and demonstrated safety and efficacy as well as improved workflow and short learning curve now with two pulsed field ablation (pfa) offerings and a portfolio of electrophysiology solutions, medtronic is shaping the future of arrythmia treatment today galway, ireland , oct. 24, 2024 /prnewswire/ -- medtronic plc (nyse: mdt), a global leader in healthcare technology, today announced united states food and drug administration (fda) approval of the affera™ mapping and ablation system with sphere-9™ catheter, an all-in-one, high-density (hd) mapping and pulsed field (pf) and radiofrequency (rf) ablation catheter for treatment of persistent atrial fibrillation (afib) and for rf ablation of cavotricuspid isthmus (cti) dependent atrial flutter. with this approval, medtronic is now the first and only company with two pfa technologies available for patients with afib.
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