Medtronic’s PulseSelect PFA system and Nitron CryoConsole gain CE mark


Medtronic has received CE mark for the PulseSelect pulsed field ablation (PFA) system and the Nitron CryoConsole.

The PulseSelect system is designed to treat atrial fibrillation (AF) effectively, efficiently, and safely, with a new ablation modality that uses pulsed electric fields to isolate the pulmonary veins.

This addition to the Medtronic PFA portfolio follows the March European approval of the Affera mapping and ablation System. Medtronic says that these approvals position as the only company with both single shot and focal PFA options to meet different patient and clinician needs.

“With multiple CE mark milestones, today’s announcement demonstrates our commitment to innovation and building a strong electrophysiology portfolio,” said Rebecca Seidel, president of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. “These milestones are part of our investment in the future of our cryoablation franchise with Nitron, as well as the future of pulsed field ablation with PulseSelect, following our more than ten years of scientific research and development.”


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