Medtronic's PulseSelect™ Pulsed Field Ablation System receives FDA approval for atrial fibrillation treatment

Medtronic has received FDA approval for its PulseSelect Pulsed Field Ablation (PFA) System, making it the first PFA technology to be approved. The system provides a safe and effective treatment for both paroxysmal and persistent atrial fibrillation (AF). It offers differentiated safety features, rapid pulmonary vein isolation, and a seamless transition to PFA in a clinician's workflow. The approval follows the recent European CE Mark of the PulseSelect PFA system. Commercialization is set to begin in early 2024.