Devices

FDA Approves Medtronic’s Pulsed Ablation

FDA has approved a Medtronic PMA for the PulseSelect Pulsed Field Ablation (PFA) System for treating both paroxysmal and persistent atrial fibrillation (AF). The company says this is the first PFA technology to receive FDA approval.

Approval was based on data from the PULSED AF study, which showed a 0.7% safety event rate and clinical success rates of 80% in both paroxysmal and persistent AF patients, Medtronic says. The device was “engineered with differentiated safety features and provides rapid, effective pulmonary vein isolation (PVI) through consistent and predictable energy delivery and catheter maneuverability,” it adds.

The company says PulseSelect can be used with any mapping system or with just fluoroscopy. It features fixed spacing for the nine-electrode catheter, which produces a consistent electric field for contiguous ablation. Additionally, the nine electrodes can be used for pacing and sensing, it says.

FDA Approves Medtronic’s Pulsed Ablation

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