Kardium receives Health Canada approval to sell device treating common heart problem

Canadian medical-device maker Kardium Inc. has received regulatory approval from Health Canada to sell a device that helps treat one of the world’s most common heart-rhythm problems.

The device is meant to treat atrial fibrillation, a serious medical condition which causes a fast and uneven heartbeat.

The Health Canada licence is another major step forward for the Vancouver-based company, which received approval from the United States Food and Drug Administration last fall to bring the same device to the American market.

Kardium was founded in 2007 with the goal of delivering better treatment for atrial fibrillation, in which irregular rhythm can halt blood flow, leading to blood clots, strokes and heart failures.

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.

Has Canada’s biotech moment finally arrived?

Developed in Canada, the company’s product is known as a pulsed field ablation device, called the Globe Pulsed Field System.

It is a sphere that is 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, and is then expanded into its spherical shape once it reaches the heart. The device uses an advanced mapping system to detect the electrical signals that are causing irregular rhythms. It 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 said 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.

In 2025, results from a global clinical study showed that 77.8 per cent of 183 patients were free of atrial fibrillation 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 gets FDA greenlight to sell in the U.S. device that treats common heart problem

Kardium’s device has been used commercially on patients in the U.S. The company has also applied for regulatory approval in Europe.

The 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 in the next two years, Mr. Chaplin said.

The company has the capacity to make up to 50,000 devices annually. They are each used once, and sell for US$10,000 to US$12,000.

“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,” he said.

The company will continue to develop the existing technology through software and hardware, and will potentially develop further medical technologies.

The device is manufactured in Vancouver, and Kardium is planning to expand its facilities.

“We’ve built a built an R&D and manufacturing centre here in Vancouver, and we’ll continue to drive innovation here,” he said.

With reports from Sean Silcoff