Kardium Inc., a private medical device company working to improve treatments for atrial fibrillation (AF), announced that Health Canada has granted approval for the Globe® Pulsed Field System. This cardiac ablation device, which is designed to streamline AF treatments, was first approved in the United States in 2025 and is now moving into Canada. The system stands out for combining high-density mapping and ablation into a single catheter, allowing for greater precision and efficiency in procedures.
What the approval means
For Kardium, Health Canada approval marks a key step in their growth as a Canadian-based company. CEO Kevin Chaplin said the milestone is especially significant given the company’s origins. He noted that the Globe System is already well-received in the U.S. and now physicians in Canada will have access to this advanced tool. The device, built in Canada, offers both single-shot and customized ablation, which are intended to cut down on procedure time and enhance patient outcomes through more efficient care.
Clinical results
Data from the pivotal PULSAR clinical trial demonstrated that 78% of patients with paroxysmal AF remained free from atrial arrhythmia one year after treatment. Importantly, the study found no primary safety events related to the device, highlighting its favorable safety profile. Dr. Atul Verma from McGill University in Montreal, who has studied the system, praised it for enabling durable and effective treatment of AF. He noted that integrating high-density mapping with ablation allows doctors greater confidence in delivering long-lasting results for patients.