Results came out of the PULSE-EU trial of the company’s Globe system. Vancouver, British Columbia-based Kardium had its findings presented at HRS 2024 earlier this month and published in the Heart Rhythm Journal.
Dr. Vivek Reddy of Mount Sinai Hospital in New York presented the data. Results highlighted Globe’s treatment of AFib, 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,” Reddy said, according to a news release. “These outcomes underscore the tremendous potential of the Globe system in advancing AFib treatment and improving patient outcomes.”
Results demonstrated acute isolation in 100% of pulmonary veins (PVs). Freedom from atrial arrhythmia at one year came in at 84.2% in paroxysmal AFib patients. It registered at 80% in persistent AFib patients. Kardium reported zero device- or procedure-related major adverse events, as Reddy said.
Average time to isolate all PVs came in at 23 minutes. Kardium reported true single-shot isolation with an average of just 1.2 pulsed field applications per PV. The company also saw a low average fluoroscopy time of just five minutes.
“These excellent results of the PULSE-EU trial reflect Kardium’s ongoing dedication to develop the best treatment for Atrial Fibrillation”, said CEO Kevin Chaplin. “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.”
Kardium also has an ongoing FDA investigational device exemption (IDE) study that kicked off last year.
