Health Canada has granted a Medical Device Licence for the Globe pulsed field system, an integrated cardiac mapping and ablation platform made by private medical device company Kardium.
The Canadian licence follows the product’s launch in the US after approval by the US Food and Drug Administration (FDA) in 2025.
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Kardium said the decision was the next step in widening access to the platform, which was developed in Canada.
According to the company, the Globe system is the only integrated, high-density cardiac mapping and ablation system of its kind. It allows physicians to carry out both single-shot pulmonary vein isolation (PVI) and customisable, targeted ablation using a single catheter.
The system combines a spherical array of 122 electrodes with real-time thermal contact sensing and visualisation tools intended to guide ablation strategy and confirm treatment.
Kardium CEO Kevin Chaplin said: “Health Canada approval represents another important milestone for Kardium and is especially meaningful as a Canada-based company.
“Following the successful introduction of the Globe system in the US, we are excited to bring this innovative technology to physicians and patients in Canada.”
Kardium pointed to results from its pivotal PULSAR study. The trial reported 78% freedom from atrial arrhythmia at one year among patients with paroxysmal atrial fibrillation (AF), no device-related primary safety events and 95% lesion durability.
In September, Kardium said the FDA had issued pre-market approval for the Globe system, along with 510(k) clearance for the Globe introducer sheath and for the system’s mapping software.
In October, the company reported that the first commercial procedures using the platform had been completed.
The platform comprises four components, which include the Globe catheter, the Globe introducer, the Globe mapping software and the Globe PF generator.
Kardium describes it as designed to deliver tailored, tissue-specific therapy, with dense electrode coverage intended to support precise lesion creation. The company has said the system is designed to improve outcomes, streamline workflows and expand treatment options for people with the condition.
