Kardium announced that it received CE Mark approval in Europe for its Globe mapping and ablation system for treating atrial fibrillation (AF).
Vancouver, B.C.-based Kardium’s spherical Globe catheter is comprised of 122 electrodes to provide electrophysiologists with single-shot pulmonary vein isolation, high-definition mapping and atrial ablation, according to a news release.
Approval in Europe came off the back of positive results from the company’s Global-AF multi-center study that demonstrated the safety and effectiveness of the Globe system.
“This is an important milestone both for Kardium and the global AF community,” Kardium CEO Kevin Chaplin said in the release. “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.”
Commercial sales and support for the Globe system in Europe will be handled by Kardium GmbH, which the company has stationed in Dortmund, Germany.