The Globe® Pulsed Field System is the most complete solution for atrial fibrillation, offering single-shot pulmonary vein isolation, high-definition mapping, and atrial ablation – all in a single catheter.
The PULSE-EU trial has shown promising early results for the treatment of atrial fibrillation.
DURABLE CLINICAL EFFECTIVENESS:
- Freedom from atrial arrhythmia at 1 year of 84% in paroxysmal atrial fibrillation patients and 80% in persistent atrial fibrillation patients.
- Acute pulmonary vein isolation (PVI) was achieved in 100% of pulmonary veins.
ENHANCED PROCEDURAL SAFETY:
- Zero device or procedure-related major adverse events (defined as esophageal complications, pulmonary vein stenosis, pericardial tamponade, phrenic nerve palsy or death)
EFFICIENT PROCEDURAL WORKFLOW:
- True single-shot isolation with an average of just 1.2 PF applications per pulmonary vein.
- Average time to isolate all pulmonary veins in a first-in-human study was 23 minutes.
- Low average fluoroscopy time of only 5 minutes, including transseptal crossing.
TRUE SINGLE-SHOT PVI WITH 1 POSITION PER VEIN
The Globe Pulsed Field System is a powerful multielectrode mapping and ablation solution that consists of a sophisticated catheter with 122 electrodes that provides rapid, single-shot PVI and the ability to quickly confirm PV isolation during ablation.
- The Globe Catheter has a 30 mm spherical array when deployed. Its 122 electrodes generate high-definition anatomical and electrical maps, as well as deliver pulsed electric field energy to ablate tissue to treat AF. PVI can typically be achieved without repositioning the catheter multiple times in each pulmonary vein. Electrophysiologists can also create focal and linear lesions elsewhere in the left atrium.
CONTINUOUS HD MAPPING
The Globe Pulsed Field System is the only system that continually records and displays the electrical activity of the atrium, showing the signals from all 122 electrodes before and after ablation. This allows electrophysiologists to confirm isolation, quickly find and eliminate gaps, or find non-PV triggers – in real-time.
High-definition mapping elements include:
- GPS™ 3D Maps show the position of the Globe Catheter in the heart;
- FLOW™ and CONTACT™ Maps show contact with tissue;
- Voltage Maps in real-time before, during, and after ablation; and
- WAVE™ Map shows atrial activation even during ablation.
SINGLE CATHETER, ALL-IN-ONE SOLUTION
The Globe Pulsed Field System combines best-in-class technologies into a single catheter, combining the rapid PVI of balloon catheters, the flexibility of single-tip catheters, and the HD mapping of multi-electrode catheters. Complete functionality is available to the electrophysiologist without the need to change catheters.
PUBLICATIONS
May 2024: 1-year outcomes of the first-in-human PULSE-EU trial, with results published in the Heart Rhythm Journal.
May 2023: The Globe PF System was shown to safely isolate pulmonary veins with good durability in the PULSE-EU trial, with results published in the Journal of American College of Cardiology: Clinical Electrophysiology.
May 2023: Circumferential, linear, and focal mapping and ablation can be achieved with the Globe Catheter using both PF and RF, with excellent efficacy and safety. Results published in the Journal of American College of Cardiology: Clinical Electrophysiology.
December 2022: The Globe PF System provides the complete solution with HD mapping and ablation for atrial fibrillation, published in Heart International.
October 2019: The Globe Mapping and Ablation System successfully demonstrated safety and efficacy in the GLOBAL-AF study, with results published in the Journal of Cardiovascular Electrophysiology.