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Kardium is set to commercially debut its Globe Mapping and Ablation System in Europe, following the receipt of CE mark approval.
The Globe System is an effective solution for the treatment of atrial fibrillation (AF).
It consists of a catheter with 122 electrodes and advanced software to enable rapid pulmonary vein isolation and high-resolution mapping. The system also offers the ability to ablate anywhere in the left atrium.
Furthermore, the Globe System provides a comprehensive solution to treat both paroxysmal and persistent AF.
Kardium noted that the CE mark approval was based on the positive results from the GLOBAL-AF study that demonstrated the safety and effectiveness of the device.
The multicentre study enrolled 60 patients at two centres in Europe. Patients were assessed for atrial fibrillation with seven-day continuous Holter monitoring at discharge and then three, six and 12 months after the treatment.
The study noted that patients in the efficacy cohort had 100% pulmonary vein isolation and 76% freedom from atrial fibrillation at 12 months off antiarrhythmic drugs after a single treatment with the Globe system.
AF is considered to be one of the most common heart rhythm disorders and it affects over 37 million people around the world. The condition can increase the risk of stroke by up to five times.
The company has formed Kardium GmbH in Dortmund, Germany, to carry out the commercial sales of the Globe System in Europe.
Kardium was founded in 2007 and is headquartered in Vancouver, Canada.