EnSite™ X EP System
Abbott MedicalThe EnSite™ X EP System is a computerized diagnostic tool that helps visualize and map the electrical activity of the heart during electrophysiological procedures. It displays the 3D position of catheters inside the heart and creates detailed maps of cardiac chambers to aid clinicians in diagnosing and treating heart rhythm disorders.
Intended Use
The EnSite X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. It provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological procedures.
Technology
The system is a catheter navigation and mapping system capable of displaying 3D positions of electrophysiology catheters and visualizing cardiac electrical activity as waveform traces and 3D isopotential and isochronal maps, based on patient anatomy. It creates a cardiac chamber model by collecting anatomic locations with catheter electrodes.
Performance
Non-clinical design verification activities including software verification, amplifier and workstation design verification, and system design validation were performed to ensure substantial equivalence to predicate devices without raising new safety or effectiveness questions.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/22/2025
3 months - 2
FDA Approval
7/30/2025
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