Health Canada Approves Integrated Mapping and Pulsed Field Ablation System for AF

Kardium Inc. has received a Medical Device Licence from Health Canada for the Globe Pulsed Field System, expanding access to its integrated mapping and pulsed field ablation platform. The authorization follows the system’s U.S. launch after receiving U.S. Food and Drug Administration (FDA) approval in 2025. Developed in Canada, the system is intended for the treatment of atrial fibrillation (AF).

The Globe Pulsed Field System combines a 122-electrode spherical array, real-time thermal contact sensing, and advanced visualization tools. It is described as the only integrated high-density cardiac mapping and ablation system that enables both single-shot pulmonary vein isolation and customizable, targeted ablation with a single catheter. These capabilities are designed to support personalized treatment strategies while streamlining AF ablation workflows.

Clinical data 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, with no device-related primary safety events reported. The findings support the system as a durable, safe, and effective approach to AF treatment.