www.fdanews.com/articles/197886-kardium-earns-ce-mark-for-globe-mapping-and-ablation-system
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Kardium Earns CE Mark for Globe Mapping and Ablation System
July 2, 2020
Canadian devicemaker Kardium has received a CE mark for its Globe Mapping and Ablation System for treatment of atrial fibrillation.
The Globe system includes a spherical catheter with 122 electrodes used for ablation and software that provides high-definition mapping. The CE mark certification was based on positive results from a multicenter safety and efficacy trial.
Kardium has formed a subsidiary in Germany to handle commercial sales of the system in Europe.