Kardium has announced that it has received premarket approval (PMA) for the Globe pulsed field ablation (PFA) system, and 510(k) clearance for both the Globe introducer sheath and the Globe PFA system mapping software, from the US Food and Drug Administration (FDA).
The Globe system is the only integrated, high-density cardiac mapping and ablation system that enables single-shot pulmonary vein isolation (PVI), as well as customisable, targeted ablation—all using a single catheter—according to Kardium. This novel platform is designed to improve outcomes, streamline workflows, and expand treatment options for patients with atrial fibrillation (AF), the company also claims in a recent press release.
“The US FDA approval of the Globe system represents the most significant milestone in the life of Kardium,” said Kevin Chaplin, chief executive officer (CEO) of Kardium. “We are extremely proud of the achievements of the team to deliver on our mission of developing the best treatment for AF. The Globe system supports a personalised, efficient and effective AF treatment.”
“I am excited to have the Globe system available in the USA,” added Vivek Reddy (Mount Sinai Fuster Heart Hospital, New York, USA). “The ability of the Globe system to achieve highly durable lesions with an excellent safety profile, together with integrated high-density mapping and true single-shot PVI, offers a distinctive and comprehensive approach to the treatment for AF.”
The Globe system is a fully integrated cardiac mapping and ablation platform that includes the Globe catheter, Globe introducer, Globe mapping software, and Globe PF generator. Designed to deliver tailored, tissue-specific therapy, the system uniquely combines high-density mapping and PFA in a single device, Kardium states. The platform’s 122-electrode spherical array enables rapid, effective and durable single-shot PVI, and it features real-time thermal contact sensing, dense electrode coverage for precise lesion creation, and advanced visualisation tools to guide ablation strategy and confirm treatment success.
Clinical data from the pivotal PULSAR study of the Globe system were presented at the 2025 Heart Rhythm Society (HRS) annual meeting (24–27 April, San Diego, USA), demonstrating a one-year freedom from atrial arrhythmia of 78% in paroxysmal AF patients and a 0% rate of device-related primary safety events.
