Vancouver-based Kardium has achieved a major milestone with U.S. Food and Drug Administration (FDA) approval of its Globe® Pulsed Field System, clearing the way for its atrial fibrillation (AF) treatment technology to enter the American market.
The company also secured 510(k) clearance for its Globe® Introducer sheath and Globe® Pulsed Field System mapping software.
The Globe System is the only integrated, high-density cardiac mapping and ablation platform that combines single-shot pulmonary vein isolation (PVI) with customizable, targeted ablation — all through a single catheter. Featuring a 122-electrode spherical array, the system enables rapid, durable PVI and precise lesion creation supported by real-time thermal sensing and advanced visualization tools.
Clinical data from the pivotal PULSAR study, presented earlier this year at the Heart Rhythm Society annual meeting, demonstrated freedom from atrial arrhythmia at one year in 78% of paroxysmal AF patients, with zero device-related primary safety events.
“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 our team for delivering on our mission of developing the best treatment for AF.”
Dr. Vivek Reddy of The Mount Sinai Fuster Heart Hospital in New York welcomed the U.S. arrival of the technology. “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 treating atrial fibrillation.”
The approval follows Kardium’s USD $250 million oversubscribed financing round this summer, led by Janus Henderson Investors, Qatar Investment Authority, MMCAP, Piper Heartland Healthcare Capital, Eventide Asset Management, and Eckuity Capital. The funding underscored investor confidence in the company’s vision and momentum.
With regulatory approval now secured, Kardium is poised to bring its Vancouver-born innovation to the world’s largest healthcare market — a major win for Canada’s medtech sector.
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