Kardium Receives FDA Approval for Atrial Fibrillation Device Treatment

Kardium, a Canadian life-sciences company, has received FDA approval to sell its medical device for treating atrial fibrillation in the US. The device, which combines several existing approaches, has generated better clinical results than rivals. Kardium plans to submit for approval in Canada and Europe and hopes to enter those markets in 2026. The company has raised over $550 million from investors and expects significant sales from its product.

Kardium, a Canadian life-sciences company, has received FDA approval to sell its medical device for treating atrial fibrillation (AF) in the United States. The device, known as the Globe Pulsed Field System, combines several existing approaches to provide a more effective treatment for AF. This approval comes after a successful clinical trial demonstrated impressive results, including a 100% procedure success rate and zero device-related complications [1].

The Globe System is designed to provide single-shot isolations of the pulmonary veins, which are the origin points for most cases of irregular heartbeat. The system uses 122 individually controllable electrodes to record cardiac activity, measure tissue contact, and deliver pulsed field ablation that disrupts heart muscle cells without damaging nearby tissues [2]. This novel approach has shown significant clinical benefits, with 78% of treated patients demonstrating freedom from AF after one year [1].

Kardium has been actively raising funds to support its commercial launch. In July 2025, the company raised $250 million in venture capital, adding to the $104 million it obtained in 2024. The total funding raised by Kardium now exceeds $550 million [1]. The company plans to submit for approval in Canada and Europe and expects to enter those markets in 2026, further expanding its reach and potential sales [1].

The Globe System's approval represents a significant milestone for Kardium, as it positions the company to compete against established players in the AF treatment market, such as Boston Scientific, Medtronic, and Johnson & Johnson [1]. The device's unique features, including high-density mapping and single-shot pulmonary vein isolation, offer a personalized and efficient treatment option for patients with AF [2].

With this FDA approval, Kardium is well-positioned to capture a significant share of the growing AF treatment market. The company's innovative approach and strong clinical data make it a compelling investment opportunity for financial professionals and investors.

References:
[1] https://www.fiercebiotech.com/medtech/kardium-grabs-fda-approval-globe-pulsed-field-ablation-catheter-afib
[2] https://www.morningstar.com/news/business-wire/20250903644547/kardium-receives-fda-approval-of-the-globe-pulsed-field-system