- Kardium received Health Canada approval for its Globe Pulsed Field System, expanding access to its integrated cardiac mapping and pulsed field ablation platform after its US launch following FDA approval in 2025.
- Developed in Canada, the Globe System is the only integrated high-density mapping and ablation platform that enables both single-shot pulmonary vein isolation (PVI) and targeted ablation using a single catheter, combining a 122-electrode spherical array, real-time thermal contact sensing, and advanced visualization tools.
- The approval is supported by data from the pivotal PULSAR study, where the Globe System achieved 78% freedom from atrial arrhythmia at one year in patients with paroxysmal atrial fibrillation, with 0% device-related primary safety events.
- Kardium said the approval marks a key milestone for the Canadian company, bringing its personalized AF treatment technology to physicians and patients in Canada while building on its commercial momentum in the US.
Takeaways:
The approval should help Kardium gain early adoption in Canada by offering a single-catheter solution that combines high-density mapping and PFA with strong PULSAR data (78% 12‑month freedom from atrial arrhythmia and 0% device-related primary safety events), which can be compelling versus legacy thermal ablation and emerging PFA competitors. Over time, this could support broader commercialization, physician training, and centre-level conversions to pulsed-field workflows, while reinforcing Kardium’s position as a Canadian innovator scaling from a domestic base into international markets.
Source: Businesswire
