Globe® Pulsed Field System
Kardium Inc.The Globe Pulsed Field System is a catheter-based system designed for cardiac anatomical and electrophysiological mapping and stimulation. It helps clinicians visualize and assess electrical activity in the heart to diagnose and treat cardiac conditions more effectively by creating detailed 3D electroanatomical maps and guiding stimulation therapy.
Intended Use
Catheter-based cardiac anatomical and electrophysiological mapping and stimulation of cardiac tissue.
Technology
The Globe PF System includes a Globe Controller for signal acquisition and processing, a Globe Workstation with dedicated software for mapping and stimulation, and GPS electrodes for catheter localization using impedance-based tracking. It generates 3D geometric shell, voltage, impedance, contact, activation, and propagation maps to assist in mapping cardiac electrical activity.
Performance
Performance testing included bench, biocompatibility, usability, electrical safety and EMC, software verification and validation, cybersecurity, and packaging validation testing. Testing followed FDA-recognized standards and showed that the device meets performance criteria for intended use without raising new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/12/2025
3 months - 2
FDA Approval
6/25/2025
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