Kardium has received CE mark approval for its Globe Mapping and Ablation System for the treatment of atrial fibrillation (AF).
“This is an important milestone both for Kardium and the global AF community,” said Kevin Chaplin, CEO of Kardium. “The Globe System can now be used by electrophysiologists (EPs) across Europe to safely and effectively treat patients with AF.”
The spherical Globe catheter has 122 electrodes and, when combined with the Globe System’s software, is designed to provide the EP with single-shot pulmonary vein isolation, high-definition mapping, and atrial ablation, giving the most complete solution for treating AF, according to Kardium.
“The Globe Mapping and Ablation System has the potential to completely revolutionise the way we treat atrial fibrillation,” said Hans Kottkamp, head of electrophysiology, Sana Hospitals, Düsseldorf, Germany. “By combining single-shot ablation with high-resolution mapping and the ability to ablate anywhere in the left atrium, the Globe System gives us a comprehensive solution to treat both paroxysmal and persistent AF.”
The CE mark approval was based on the positive results from the GLOBAL-AF study, a multicentre study that demonstrated the safety and effectiveness of the Globe Mapping and Ablation System.