Canadian medical device company Kardium Inc. has received Health Canada approval to sell its pulsed field ablation device, designed to treat atrial fibrillation, a common and serious heart rhythm disorder. This marks a significant milestone for the Vancouver-based firm, which obtained U.S. Food and Drug Administration (FDA) clearance for the same device in late 2025.
Atrial fibrillation, characterized by a rapid and irregular heartbeat, affects nearly 60 million people worldwide. The condition can disrupt normal blood flow, increasing the risk of blood clots, strokes, and heart failure. Kardium was established in 2007 with the objective of improving treatment options for this condition.
The approved device, known as the Globe Pulsed Field System, is a single-use, spherical instrument roughly three centimeters in diameter. It is composed of 122 individually controlled gold electrodes. The device is initially flattened and inserted into the femoral vein before expanding to its spherical shape upon reaching the heart. Equipped with an advanced mapping system, the device identifies abnormal electrical signals responsible for irregular heart rhythms and treats them through a procedure called ablation, which uses high-voltage energy to target the cells causing the arrhythmia.
Kevin Chaplin, Kardium’s CEO, highlighted the device’s advantages over others, noting that the high number of electrodes allows for more precise mapping and faster, more effective tissue treatment. He added that the procedure is designed to be brief and safe, often allowing patients to return home the same day.
Clinical data from a 2025 global study involving 183 patients demonstrated that approximately 78 percent remained free of atrial fibrillation one year after treatment with Kardium’s system. The device also showed a favorable safety profile, with no device-related primary safety events reported, compared to reported complication rates ranging from 0.7 to 2.2 percent among competitors.
Kardium’s technology has been commercially used in the United States, and regulatory approval applications are underway for European markets. The company has secured more than US$550 million in funding from investors including the Qatar Investment Authority, Fidelity Management & Research Co., and T. Rowe Price Associates Inc., alongside various venture capital firms.
The company plans to expand manufacturing capacity beyond its current production capability of up to 50,000 units annually. Each device is single-use, with a price range between US$10,000 and US$12,000. Kardium intends to pursue a public offering within the next two years.
Manufactured in Vancouver, the device is part of Kardium’s ongoing commitment to research and development at its local facility, which the company aims to grow further. Chaplin affirmed the company’s focus on continued innovation both in software and hardware, as well as potential development of new medical technologies.