June 30, 2020
Kardium Inc. reported they have received CE mark approval for its Globe® Mapping and Ablation System – the most complete solution for the treatment of atrial fibrillation (AF).
Kardium reminds us that AF is the world’s most common heart rhythm disorder, affecting more than 37 million people. This approval allows Kardium to begin commercial sales of the Globe System in Europe.
“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. We have a sales and support team in place and are now launching the Globe System for clinical use in Europe.”
The spherical Globe catheter has 122 electrodes and, when combined with the Globe System’s sophisticated software, is the only device that provides the EP with single-shot pulmonary vein isolation, high-definition mapping, and atrial ablation, giving the most complete solution for treating AF.
“The Globe Mapping and Ablation System has the potential to completely revolutionize the way we treat atrial fibrillation,” said Prof. Hans Kottkamp, Head of Electrophysiology, Sana Hospitals, Düsseldorf. “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 multi-center study that demonstrated the safety and effectiveness of the Globe Mapping and Ablation System.
Kardium GmbH has been formed in Dortmund, Germany to handle commercial sales of the Globe System in Europe.