Kardium's Globe Pulsed Field System secures Health Canada approval for atrial fibrillation treatment
核心洞察
Kardium Inc. received Health Canada approval to sell its Globe Pulsed Field System (搜索), a pulsed field ablation device for treating atrial fibrillation (搜索), following FDA approval in August 2025.
The device uses 122 individually controlled electrodes for high-density mapping and ablation, with a global study showing 77.8% of 183 patients free of atrial fibrillation (搜索) at 12 months.
The Vancouver-based company received a $31.25-million federal funding boost to expand clean room manufacturing capacity from 10,000 to 25,000 square feet.
Canadian medical-device maker Kardium Inc. has received regulatory approval from Health Canada to sell its Globe Pulsed Field System (搜索), a device designed to treat atrial fibrillation (搜索), one of the world's most common heart-rhythm problems. The approval marks another major milestone for the Vancouver-based company, which received clearance from the United States Food and Drug Administration in August 2025 to bring the same device to the American market.
Atrial fibrillation (搜索) is a serious medical condition that causes a fast and uneven heartbeat. The irregular rhythm can halt blood flow, leading to blood clots, strokes and heart failure. The condition affects almost 60 million people around the world.
"It's a huge problem, and we've developed a much better system for diagnosing and treating it," Kevin Chaplin, Kardium's chief executive officer, said in an interview.
How the Globe Pulsed Field System Works
Developed in Canada, the company's product is a pulsed field ablation device called the Globe Pulsed Field System (搜索). It is a sphere three centimetres in diameter, made up of 122 golden, individually controlled electrodes.
The single-use device is first flattened and inserted into the femoral vein, then expanded into its spherical shape once it reaches the heart. The device uses an advanced mapping system to detect the electrical signals causing irregular rhythms, then treats those signals by zapping the cells using high-voltage energy — a procedure called ablation.
"Then we remove the device, and the patient goes home the same day," Mr. Chaplin said. "We've made the procedure safe, more effective, and very fast for the physician to give the patient the treatment."
Mr. Chaplin noted that other pulsed field ablation devices on the market contain fewer electrodes. Kardium's 122 electrodes provide "higher-density mapping to find the electrical signals, and more electrodes for treating the tissue faster and more effectively," he added.
Clinical Evidence
In 2025, results from a global clinical study showed that 77.8 per cent of 183 patients were free of atrial fibrillation (搜索) 12 months after being treated with Kardium's technology. Additionally, there were no device-related "primary safety events," compared to competitors reporting between 0.7 per cent and 2.2 per cent adverse safety events.
Kardium's device has been used commercially on patients in the U.S., and the company has also applied for regulatory approval in Europe.
Manufacturing Expansion and Federal Support
Kardium is receiving a $31.25-million funding boost from the federal government's Strategic Response Fund to expand its manufacturing capabilities in the greater Vancouver area. The funding will support a $125-million investment project by the Burnaby, B.C.-based company to more than double its clean room facilities as it scales up manufacturing.
The company's manufacturing process requires each device to be assembled in clean rooms, which are kept free of dust, germs and polluted air, and each equipped with their own heating, ventilation and air-conditioning system. The company currently has 10,000 square feet of clean room space; with the investment, that will increase to 25,000.
"We're building Kardium to be an independent company and in order to do that we want to have control of our own destiny. That means controlling our own manufacturing," Mr. Chaplin said.
The company now has more than 700 employees and has added 200 this year for manufacturing. The facility in Burnaby is one of two that Kardium will use to manufacture its devices as it expands globally. The company plans to open another facility in Costa Rica, a major centre for medical device manufacturing, by 2029, which will ultimately supply a majority of its devices globally.
The company has the capacity to make up to 50,000 devices annually. Each device is used once and sells for US$10,000 to US$12,000.
Company Outlook
Kardium was founded in 2007 with the goal of delivering better treatment for atrial fibrillation (搜索). The privately held 19-year-old company has raised more than US$550-million from investors, including sovereign wealth fund Qatar Investment Authority, Fidelity Management & Research Co., T. Rowe Price Associates Inc. and several venture-capital firms.
Kardium has plans to go public as early as the second half of 2027. The company will continue to develop the existing technology through software and hardware, and will potentially develop further medical technologies.
"We've worked with a number of leading Canadian doctors over the years, and it's really exciting to finally be able to start using the device in Canada," Mr. Chaplin said. "We've built an R&D and manufacturing centre here in Vancouver, and we'll continue to drive innovation here."