Medtronic says FDA approves novel PulseSelect system

Medtronic announced that the United States Food and Drug Administration (FDA) has approved the PulseSelect Pulsed Field Ablation (PFA) System for the treatment of both paroxysmal and persistent atrial fibrillation (AF). This is the first PFA technology to receive FDA approval and follows the recent European CE (Conformite Europeenne) Mark of the PulseSelect PFA system in November. “Launching the first FDA-approved PFA technology is not just a milestone; the PulseSelect PFA system is setting a new standard in safety for AF ablation with excellent efficacy and efficiency. It’s a major step towards fulfilling our vision of providing disruptive electrophysiology solutions for patients,” said Rebecca Seidel, SVP and President of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio. “The PulseSelect PFA system, together with the CE Marked Affera(TM) mapping and ablation system and our strong Cryo platform, enables us to provide a broad portfolio of solutions to clinicians and their patients, all developed with years of research and supported by compelling scientific evidence.”