Kardium Receives Health Canada Approval for Globe Pulsed Field System
Kardium Inc., a Canadian medical device company, has received a Medical Device Licence from Health Canada for its Globe® Pulsed Field System, expanding access to its atrial fibrillation (AF) treatment technology in Canada.
The approval follows the system’s US launch after receiving FDA approval in 2025.
The Globe System integrates high-density cardiac mapping and pulsed field ablation within a single catheter.
It is designed to support both single-shot pulmonary vein isolation (PVI) and targeted ablation, enabling physicians to tailor procedures to individual patient needs.
The system features a 122-electrode spherical array, real-time thermal contact sensing and advanced visualisation tools.
These capabilities are designed to support accurate mapping, treatment planning and efficient AF ablation workflows.
Clinical findings from the pivotal PULSAR study demonstrated the system’s safety and effectiveness in patients with paroxysmal AF.
At one year, 78% of patients remained free from atrial arrhythmia, while no device-related primary safety events were reported.
The Health Canada approval marks an important milestone for Kardium as it expands the availability of the Globe System.
The company aims to provide physicians with an integrated platform that combines cardiac mapping and ablation to support more personalised and efficient AF treatment.
