Medtronic today announced 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 one of the first companies 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.
With a trailblazing design, the Sphere-9 catheter offers physicians the option of both PF and RF energy delivery, fully integrated with the Affera Mapping and Ablation System. The Sphere-9 catheter enhances workflow efficiency for physicians while providing excellent safety and efficacy outcomes.
The approval was based on excellent results demonstrated in the pivotal SPHERE Per-AF study, an FDA Investigational Device Exemption (IDE) trial, which compared the Sphere-9 catheter with the Affera Mapping and Ablation System to the conventional Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto3 System. The Affera Mapping and Ablation System and Sphere-9 catheter also received CE Mark in March 2023 and was approved in Australia in September 2024. In October 2024, Medtronic announced the start of an early feasibility study to evaluate the Sphere-9 catheter for treatment of ventricular tachycardia (VT), a cardiac arrhythmia in which the lower chamber of the heart beats abnormally fast.
