Kardium said it has received pre-market approval (PMA) for the Globe Pulsed Field System and 510(k) clearance for both the Globe Introducer sheath and the Globe Pulsed Field System mapping software from the FDA.
The Globe System is an integrated, high-density cardiac mapping and ablation system that enables single-shot pulmonary vein isolation (PVI), as well as customizable, targeted ablation – all using a single catheter. This novel platform is designed to improve outcomes, streamline workflows, and expand treatment options for patients with atrial fibrillation.
It features a 122-electrode spherical array and real-time thermal contact sensing, dense electrode coverage for precise lesion creation, and advanced visualization tools to guide ablation strategy and confirm treatment success.
