One-Year Trial Data Show Kardium’s Globe System Can Improve Afib Treatment

Kardium Inc. is sharing positive one-year study results of the first-in-human PULSE-EU Trial for its Globe System, designed to treat atrial fibrillation (Afib). 

“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 in New York City. “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 PF dose included:

Durable Clinical Effectiveness:

• Acute PV isolation was achieved in 100% of pulmonary veins.
• Freedom from atrial arrhythmia at 1 year of 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 5 minutes.

“These results of the PULSE-EU Trial reflect Kardium’s ongoing dedication to develop the best treatment for Atrial Fibrillation,” Kardium CEO Kevin Chaplin said. “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 for patients worldwide.”

Kardium Inc. is a growing, privately held medical solutions company that has developed an advanced system for atrial fibrillation (AF) treatment: the Globe System. The company was founded in 2007 and is headquartered in Vancouver, Canada.