FDA approves first pulsed field AF ablation system

Medtronic’s pulsed field ablation system, PulseSelect, has been approved by the FDA for the treatment of paroxysmal and persistent atrial fibrillation. This is the first pulsed field ablation system to receive FDA approval. The approval is based on the positive results of the PULSED AF pivotal trial, which showed low rates of adverse events and effectiveness consistent with established ablation strategies. The system’s plug-and-play design allows it to be used with any mapping system or with just fluoroscopy, and includes built-in safety features. Clinical trial results and expert feedback indicate that the system offers safe, effective, and efficient AF ablation with a short learning curve.

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