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proxis system model eps 101
Velocimed
Summary: The Proxis System Model EPS 101 is a venous stent device used primarily in vascular interventions to support vein patency. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K042117 ↗
Decision Date
January 7, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Proxis System Model EPS 101 was cleared via the FDA 510(k) pathway on January 7, 2005. Manufactured by Velocimed, it is classified as a Class 2 device under product code DQY.
What It Is
The Proxis System Model EPS 101 is a venous stent designed to maintain open blood flow in veins, particularly in cases where venous obstruction is present. It is a tubular device that is implanted within the vein to prevent collapse and ensure adequate blood circulation. This system is particularly useful in treating conditions such as venous insufficiency or post-thrombotic syndrome.
Clinical Applications
This device is commonly used in procedures involving venous stenting, especially in patients with chronic venous insufficiency or those who have experienced deep vein thrombosis. Interventional radiologists and cardiologists often deploy this device in hospital settings during minimally invasive procedures. It is suitable for adult patients who require long-term venous support to prevent complications from venous obstructions.
Indications for Use
The FDA indications for the Proxis System Model EPS 101 suggest its use in patients with venous obstructions that require stenting to maintain blood flow. It is particularly indicated for conditions where veins are at risk of narrowing or collapsing.
Practical Considerations
The Proxis System Model EPS 101 comes in various sizes to accommodate different vein diameters and is compatible with standard catheter delivery systems. Clinicians should ensure proper sizing and placement technique to optimize outcomes and reduce the risk of complications.
Frequently Asked Questions
What is Proxis System Model EPS 101 used for?
It is used to maintain open blood flow in veins by providing structural support, particularly in cases of venous obstruction.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in vascular interventions.
What are the FDA-cleared indications?
The device is indicated for use in patients with venous obstructions requiring stenting to maintain proper blood flow.
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.