December 18, 2023 – Medtronic introduced that the U.S. Meals and Drug Administration (FDA) has accredited the PulseSelect Pulsed Subject Ablation (PFA) System for the therapy of each paroxysmal and protracted atrial fibrillation (AF). That is the primary PFA know-how to be accredited by the FDA and follows the current European CE (Conformité Européenne) marking of the PulseSelect PFA system in November.
Designed with differentiated security options, the PulseSelect PFA System gives speedy, efficient pulmonary vein isolation (PVI) by constant and predictable power supply and catheter maneuverability. The system is designed to allow a seamless transition to PFA within the doctor's most well-liked workflow2. The security, efficacy and effectivity of the PulseSelect PFA System are supported by the PULSED AF examine, which demonstrated a security occasion fee of 0.7% and medical success charges of 80% in each paroxysmal and protracted AF sufferers.
Be taught extra