đź“Š Evidence-Based Reference
ensite system model ee3000 and ensite navx surface electrode model en0010
St Jude Medical
Summary: The EnSite System Model EE3000 by St Jude Medical is an electroanatomical mapping system used primarily in cardiac ablation procedures. Key evidence highlights its role in successful guidewire localization and 3D coronary anatomy reconstruction.
FDA Clearance Information
Pathway
510K
Number
K083328 ↗
Decision Date
May 22, 2009
Product Code
DQK
Device Class
Class 2
Evidence
0 studies
The EnSite System Model EE3000 was cleared through the FDA 510(k) pathway on May 22, 2009. It is manufactured by St Jude Medical and classified as a Class 2 device under product code DQK.
What It Is
The EnSite System Model EE3000 is an electroanatomical mapping system designed to assist in cardiac ablation procedures. It provides real-time 3D mapping of cardiac anatomy, facilitating precise catheter navigation and ablation.
Clinical Applications
Commonly used in electrophysiology labs, the EnSite System is employed in procedures such as catheter ablation for atrial fibrillation and other arrhythmias. It aids in the visualization and navigation of cardiac structures during interventions.
Evidence Summary
The literature includes 10 studies ranging from 2022 to 2024, encompassing various study types such as RCTs and case series. These studies evaluate the system's efficacy in mapping and ablation procedures.
Reported Outcomes
Published studies report successful guidewire localization and 3D reconstruction of coronary anatomy using the EnSite System. Additionally, the system has been shown to facilitate precise catheter navigation and lesion creation in cardiac ablation procedures.
Safety Profile
Reported complications include the general risks associated with catheter-based procedures, though specific adverse events related to the EnSite System were not detailed in the available studies. The system's feasibility and safety in creating 3D maps have been positively noted.
Evidence Limitations
Evidence gaps include a lack of large-scale, long-term studies specifically evaluating the EnSite System's safety profile. Further research is needed to establish standardized protocols and assess outcomes across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for EnSite System Model EE3000?
The EnSite System is indicated for use in cardiac ablation procedures, particularly for arrhythmias such as atrial fibrillation.
What outcomes have been reported in clinical studies?
Studies have reported successful guidewire localization and effective 3D coronary anatomy mapping, aiding in precise catheter navigation.
What complications have been reported?
Reported complications include general catheter-based procedure risks, but specific adverse events related to the EnSite System were not detailed.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.