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  • CE Mark approval for Affera Mapping and Ablation S...

CE Mark approval for Affera Mapping and Ablation System to treat atrial arrhythmias.- Medtronic Inc.

Read time: 1 mins
Published:16th Mar 2023

Together, the full system creates a new paradigm in electrophysiology through the unique integration of the Sphere-9 pulsed field ablation (PFA), radiofrequency (RF), and high density (HD) mapping catheter, which maps and ablates atrial arrhythmias (fast, abnormal heart rhythms) and provides real-time feedback through its intuitive mapping and navigation software.

The Affera Mapping and Ablation System will be commercially available beginning in the first half of 2023 in Europe and is investigational in the United States. Medtronic acquired Affera in August 2022. Worldwide, the PulseSelect System is investigational and not approved for sale or distribution. The Affera Mapping and Ablation system is limited to investigational use in the United States, Japan, and Canada.

Condition: Atrial Fibrillation
Type: drug

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