Kardium’s Globe System Shows Strong Results in AFib Trial

Kardium reported positive outcomes from its pivotal PULSAR trial (NCT05462145) of the Globe Pulsed Field System for paroxysmal atrial fibrillation (AFib). In the FDA IDE study, the system achieved durable pulmonary vein isolation (PVI) in 95% of veins after a single pulsed field application. At 12 months, 78% of patients remained free from atrial arrhythmias, highlighting Globe’s efficacy in drug-refractory AFib.

No device-related primary safety events occurred during the trial, and results were published in the Journal of the American College of Cardiology. Globe uses a single catheter with a 122-electrode array, enabling single-shot PVI and targeted ablation.

Globe already holds a CE mark in Europe and received FDA PMA and 510(k) clearance for its sheath and mapping software. Kardium has begun commercial US procedures and is partnering with electrophysiology centers to expand availability. The PFA market is growing rapidly, with projected valuations exceeding $23 billion by 2034.

25-01-2026