Kardium announces positive 1-year outcomes for PULSE-EU trial with the Globe® System, showing promise for improving the treatment of atrial fibrillation

VANCOUVER, British Columbia--(BUSINESS WIRE)--Kardium Inc., a private medical device company that has developed the Globe® System for the treatment of atrial fibrillation (AF), announced positive results of the 1-year outcomes of the First-in-Human PULSE-EU Trial. These findings were presented as late-breaking clinical data at the Heart Rhythm Society (HRS) 2024 Annual Meeting and simultaneously published in the Heart Rhythm Journal.

“I am very excited by the results of the PULSE-EU Study with the Globe Pulsed Field System” said Dr. Vivek Reddy of The Mount Sinai Hospital, New York, who presented the data at HRS. “The Globe System achieved outstanding freedom from atrial arrhythmia in both Paroxysmal and Persistent patients, with no device- or procedure-related major adverse events. These outcomes underscore the tremendous potential of the Globe System in advancing AF treatment and improving patient outcomes.”

The results demonstrated in the PULSE-EU study in patients receiving the optimized Pulsed Field (PF) dose included:

Durable Clinical Effectiveness:

• Acute isolation was achieved in 100% of pulmonary veins (PVs).
• Freedom from atrial arrhythmia at 1 year was 84.2% in paroxysmal AF patients and 80% in persistent AF patients.

Enhanced Procedural Safety:

• Zero device or procedure-related major adverse events (defined as death, phrenic nerve palsy, pericardial tamponade, pulmonary vein stenosis or esophageal complications)

Efficient Procedural Workflow:

• Average time to isolate all pulmonary veins was 23 minutes.
• True single-shot isolation with an average of just 1.2 PF applications per pulmonary vein.
• Low average fluoroscopy time of only 5 minutes.

“These excellent results of the PULSE-EU Trial reflect Kardium’s ongoing dedication to develop the best treatment for Atrial Fibrillation”, said Kevin Chaplin, CEO of Kardium. “These findings highlight the potential of the Globe System to set new standards in the treatment of atrial fibrillation, with the potential to offer a safe and more effective therapeutic option for patients. Everyone at Kardium looks forward to further advancing our Globe technology and making it available to patients worldwide.”

About Kardium

Kardium Inc. (kardium.com) is a rapidly growing, privately held medical solutions company that has developed an advanced system for atrial fibrillation (AF) treatment: the Globe System. Kardium has built an outstanding team, who have worked with top medical advisors to develop the Globe System. Founded in 2007 and headquartered in Vancouver, Canada, Kardium has consistently ranked as one of the top companies to work for in British Columbia.

This press release may contain forward-looking statements, which reflect current expectations regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, performance or achievements to be materially different from those expressed or implied by such statements. The Globe System is restricted by federal law to investigational use only, and it has not been approved or cleared for commercial distribution in any jurisdictions.