Kardium has reported positive one-year outcomes from the PULSE-EU trial of its Globe pulsed field mapping and ablation system for the treatment of atrial fibrillation (AF).
The Globe system is a multielectrode mapping and ablation solution designed for AF.
It comprises a catheter with 122 electrodes to provide rapid, single-shot PVI to quickly confirm pulmonary vein (PV) isolation during ablation.
The results from the PULSE-EU trial indicate a promising future for the device in managing this common heart condition.
The trial outcomes showed that the Globe system achieved acute PV isolation in 100% of cases.
At one year, freedom from atrial arrhythmia of 84.2% was observed in paroxysmal AF patients and 80% in persistent AF patients, highlighting the system’s durable clinical effectiveness.
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PULSE-EU reported no major adverse events related to the device or procedure such as death, pericardial tamponade, phrenic nerve palsy, pulmonary vein stenosis, or oesophagal complications.
The efficiency of the Globe system was also notable, with an average time of 23 minutes to isolate all PVs.
The procedure typically required just 1.2 pulse field (PF) applications per pulmonary vein, demonstrating true single-shot isolation.
Additionally, the average fluoroscopy time was only five minutes.
Kardium CEO Kevin Chaplin said: “These excellent results of the PULSE-EU Trial reflect Kardium’s ongoing dedication to developing the best treatment for Atrial Fibrillation.
“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.”
