A new paradigm in electrophysiology: Medtronic receives FDA approval of Affera™ Mapping and Ablation System and Sphere-9™ Catheter

With this approval, Medtronic is now the first and only company with two PFA technologies available for patients with Afib. The PulseSelect™ Pulsed Field Ablation System, which was FDA approved in December 2023, offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) while the Affera Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath. "The significance of this innovative technology should ...