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Medtronic Earns CE Mark For Affera Ablation System, Touts New PFA Results

 
• By Reed Miller

Results of the PULSED AF trial confirm that Medtronic’s PulseSelect pulsed field ablation is safe and effective for atrial fibrillation ablation. The company will likely incorporate PulseSelect into its Affera cardiac mapping and ablation system, which will soon be available in Europe.

Atrial fibrillation and normal or abnormal heart rate rythm as a cardiac disorder as a human organ with healthy and unhealthy ecg monitoring in a 3D illustration style.
• Source: Shutterstock

Medtronic’s Affera mapping and ablation system, which includes the Sphere-9 and the Affera Prism-1 mapping software, earned a CE mark and will be available in Europe by the middle of 2023, the company announced on 15 March.

Sphere-9 can create point-by-point/focal ablations with either pulsed field (PF) or radiofrequency (RF) energy while also providing high-density (HD) mapping to treat atrial arrhythmias. The Affera system was originally developed...

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