Kardium

Vancouver-based Kardium has secured U.S. Food and Drug Administration approval for its Globe® Pulsed Field System, opening the American market to its atrial fibrillation treatment technology. The firm also received 510(k) clearance for its Globe Introducer sheath and mapping software.

The Globe System integrates high-density mapping and ablation, enabling both single-shot pulmonary vein isolation and targeted ablation through a single catheter. Results from the PULSAR study showed 78% freedom from arrhythmia at one year with no device-related safety events. The FDA approval follows Kardium’s US$250 million financing round, strengthening Canada’s position in the global medtech industry.

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Vancouver-based Kardium has closed a US$250 million financing round to advance the commercialization of its Globe System for atrial fibrillation treatment. The oversubscribed round included Janus Henderson Investors, Qatar Investment Authority, MMCAP, Piper Heartland Healthcare Capital, Eventide Asset Management, and Eckuity Capital.

The Globe System features a 122-electrode array enabling rapid pulmonary vein isolation and high-resolution mapping in a single catheter. CEO Kevin Chaplin said the funding will expand manufacturing, support regulatory approvals, and build a commercial team ahead of launch later this year. Clinical data showed 78% freedom from arrhythmia at one year in paroxysmal AF patients.

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Vancouver-based Kardium has raised $143 million in a financing round led by existing investor Fidelity Management & Research Company. The funding will support the completion of the PULSAR clinical study for the Globe Mapping and Ablation System, used to treat atrial fibrillation.

The funds will also help expand Kardium’s manufacturing capabilities and build a clinical support and commercial team for the Globe System’s launch. The Globe System features a catheter with a 122-electrode array and advanced software for rapid pulmonary vein isolation and high-definition mapping.

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