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viaone epicardial access system
Cardiovia
Summary: The Viaone Epicardial Access System by Cardiovia is designed for gaining access to the epicardial space, primarily used by interventional cardiologists and electrophysiologists in procedures involving the heart's outer layer.
FDA Clearance Information
Pathway
510K
Number
K243928 ↗
Decision Date
March 20, 2025
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Viaone Epicardial Access System was cleared via the FDA 510k pathway on March 20, 2025. Manufactured by Cardiovia, it is classified as a Class 2 device under product code DYB.
What It Is
The Viaone Epicardial Access System is a medical device used to access the epicardial space of the heart. It facilitates procedures that require direct intervention on the heart's outer surface, such as epicardial ablation or lead placement. The system typically includes specialized needles and sheaths designed to safely navigate the pericardial sac and minimize the risk of complications.
Clinical Applications
This device is commonly used in electrophysiology labs and cardiac catheterization suites. It is particularly useful for patients undergoing complex arrhythmia ablations where epicardial access is necessary. Interventional cardiologists and electrophysiologists use it in settings such as hospitals and specialized cardiac centers, often for patients with refractory arrhythmias or those requiring epicardial lead placement for cardiac resynchronization therapy.
Indications for Use
The FDA indications suggest that the device is intended for use in procedures requiring access to the epicardial space. This includes patients with conditions like ventricular tachycardia or those needing epicardial lead placement.
Practical Considerations
Clinicians should consider the device's compatibility with existing catheterization lab equipment. Typical sizing may vary, so it's important to select the appropriate sheath and needle size based on patient anatomy and procedural requirements. Training in epicardial access techniques is recommended to optimize outcomes and minimize risks.
Frequently Asked Questions
What is Viaone Epicardial Access System used for?
It is used for gaining access to the epicardial space for procedures like epicardial ablation and lead placement.
What specialties typically use this device?
Interventional cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for procedures requiring access to the epicardial space, such as in patients with ventricular arrhythmias or those needing epicardial lead placement.
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.