Medtronic’s Affera ablation system granted FDA approval
The Fly

Medtronic’s Affera ablation system granted FDA approval

Medtronic (MDT) announced FDA approval of the Affera Mapping and Ablation System with Sphere-9 Catheter, an all-in-one, high-density mapping and pulsed field and radiofrequency ablation catheter for treatment of persistent atrial fibrillation and for RF ablation of cavotricuspid isthmus dependent atrial flutter. With this approval, Medtronic is now the first and only company with two PFA technologies available for patients with Afib. AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide.

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