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epi-ease epicardial access device eas
Atricure
Summary: The epi-ease epicardial access device by Atricure is designed to facilitate epicardial access for procedures like embolization. It is primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K233959 ↗
Decision Date
February 13, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The epi-ease epicardial access device received FDA clearance through the 510k pathway on February 13, 2024. Manufactured by Atricure, it is classified as a Class 2 device under product code DYB.
What It Is
The epi-ease epicardial access device is a medical tool designed to provide safe and effective access to the epicardial space. It is used in procedures that require direct access to the heart's outer surface, such as certain types of cardiac ablations or the placement of epicardial leads. The device helps clinicians navigate the pericardial space with precision, minimizing the risk of complications.
Clinical Applications
This device is commonly used in interventional cardiology and electrophysiology, particularly for procedures that involve epicardial mapping and ablation. It is utilized in settings such as cardiac catheterization labs and electrophysiology suites. The device is suitable for adult patients requiring epicardial interventions, often those with arrhythmias that cannot be addressed through endocardial approaches.
Indications for Use
The FDA indications for the epi-ease device include providing access to the epicardial space for procedures like embolization. It is intended for patients who need interventions on the heart's outer surface, often due to complex arrhythmias.
Practical Considerations
Clinicians should be aware of the device's compatibility with other cardiac intervention tools. Proper technique in accessing the epicardial space is crucial to avoid complications. Familiarity with the device's sizing and handling is important for optimal use.
Frequently Asked Questions
What is the epi-ease epicardial access device used for?
It is used to gain access to the epicardial space for procedures like cardiac ablations and the placement of epicardial leads.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device, especially in interventional and electrophysiology settings.
What are the FDA-cleared indications?
The device is indicated for providing access to the epicardial space for procedures such as embolization, particularly in patients with complex arrhythmias.
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.