Kardium Receives Health Canada Approval for the Globe® Pulsed Field System
Kardium Inc., a private medical device company that’s advancing the way the world treats atrial fibrillation (AF),
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Kardium Inc., a private medical device company that’s advancing the way the world treats atrial fibrillation (AF), announced today that Health Canada has granted a Medical Device Licence for the Globe® Pulsed Field System. Building on the successful U.S. launch of the Globe System following FDA approval in 2025, Health Canada approval marks the next major milestone in expanding access to Kardium’s integrated mapping and pulsed field ablation platform.
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The Globe mapping and ablation catheter from Kardium.
Developed in Canada, the Globe System is the only integrated, high-density cardiac mapping and ablation system that enables both single-shot pulmonary vein isolation (PVI) and customizable, targeted ablation using a single catheter. The system combines a 122-electrode spherical array, real-time thermal contact sensing, and advanced visualization tools to support personalized treatment strategies and efficient AF ablation workflows.
“Health Canada approval represents another important milestone for Kardium and is especially meaningful as a Canadian based company,” said Kevin Chaplin, CEO of Kardium. “Following the successful introduction of the Globe System in the United States, we are excited to bring this innovative technology to physicians and patients in Canada. The Globe System reflects our commitment to developing a better way to treat AF through a personalized, efficient, and effective treatment.”
“The Globe System represents an important step forward in AF ablation,” said Dr Atul Verma of McGill University in Montreal. “By combining HD mapping and ablation together in a single platform, the system provides physicians with more confidence in delivering a durable and effective treatment for patients.”
Clinical data from the pivotal PULSAR study demonstrated the safety and effectiveness of the Globe System, showing 78% freedom from atrial arrhythmia at one year in patients with paroxysmal AF, with 0% device-related primary safety events. These results demonstrate the Globe System’s ability to deliver durable, safe, and effective treatment for patients with atrial fibrillation.
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