Kardium receives FDA approval of the Globe® Pulsed Field System

VANCOUVER, British Columbia--(BUSINESS WIRE)--Kardium Inc., a private medical device company that’s advancing the way the world treats atrial fibrillation (AF), announced today 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 U.S. 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 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.

“The FDA approval of the Globe System represents the most significant milestone in the life of Kardium.” said Kevin Chaplin, 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 personalized, efficient, and effective AF treatment.”

“I am excited to have the Globe System available in the US.” said Dr. Vivek Reddy of The Mount Sinai Fuster Heart Hospital, New York. “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 atrial fibrillation.”

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 pulsed field ablation in a single device. Its 122-electrode spherical array enables rapid, effective and durable single-shot pulmonary vein isolation (PVI). The platform features real-time thermal contact sensing, dense electrode coverage for precise lesion creation, and advanced visualization tools to guide ablation strategy and confirm treatment success.

Impressive clinical data from the pivotal PULSAR clinical study of the Globe System was recently presented at the 2025 Heart Rhythm Society annual meeting. This data demonstrated remarkable results with the Globe System, showing freedom from atrial arrhythmia at 1 year of 78% in paroxysmal AF patients, with 0% device-related primary safety events.

About Kardium

We are a rapidly growing, privately held medical solutions company made up of a team of scientists, engineers and business professionals. Our mission is to deliver the best treatment for atrial fibrillation.