Medtronic’s Affera Mapping and Ablation System Receives CE Mark for the Treatment of Atrial Arrhythmias
- The company has received CE mark clearance for its Affera mapping & ablation system incl. the Sphere-9 catheter & Affera Prism-1 mapping software to treat atrial arrhythmias or fast, abnormal heart rhythms. The company plans to commercially launch the Affera system in the EU in H1’23 & is investigational in the US
- The system integrates Sphere-9 pulsed-field ablation (PFA), radiofrequency, and high-density mapping. It maps and ablates atrial arrhythmias incl. AFib provides real-time feedback through its mapping and navigation software
- The IDE pivotal trial (SPHERE Per-AF Trial) evaluates the safety & effectiveness of the Affera Mapping & Ablation System for treating persistent AF while the trial is currently in 12mos. follow up phase
Ref: Medtronic | Image: Medtronic
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