The all-in-one, high-density (HD) mapping, pulsed field ablation (PFA) and radiofrequency (RF) ablation system treats persistent atrial fibrillation (AFib) and offers RF ablation for cavotricuspid isthmus (CTI) dependent atrial flutter. Medtronic also recently received the FDA’s green light to study the system in treating ventricular tachycardia (VT).

Medical Design & Outsourcing: Medtronic’s Affera Sphere-9  catheter uses nitinol in a new way

Medtronic said the approval makes it the first and only company with two PFA technologies available for treating AFib. The medtech giant also makes the PulseSelect PFA system, which this year became the first PFA system win FDA approval. PulseSelect delivers single-shot cardiac ablation for pulmonary vein isolation (PVI), while the Sphere-9 catheter enables flexibility with a wide area focal design and 9mm lattice tip that works with an 8.5Fr sheath.