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modification to proxis system model eps 101
St Jude Medical
Summary: The Proxis System Model EPS 101 by St Jude Medical is a venous stent system used primarily in vascular procedures to support vein patency. It is typically used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K063638 ↗
Decision Date
May 11, 2007
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Proxis System Model EPS 101 was cleared through the FDA 510k pathway on May 11, 2007. Manufactured by St Jude Medical, this device is classified as Class 2 under product code DQY.
What It Is
The Proxis System Model EPS 101 is a venous stent system designed to maintain or restore patency in veins. It works by providing structural support to the vessel wall, preventing collapse or narrowing that can impede blood flow. This device is particularly useful in managing venous obstructions and is designed for easy deployment during vascular interventions.
Clinical Applications
This device is commonly used in procedures involving venous obstructions, such as those caused by chronic venous insufficiency or post-thrombotic syndrome. It is typically used in hospital settings by interventional cardiologists and vascular surgeons. The patient population includes those with compromised venous circulation, often requiring minimally invasive interventions to restore proper blood flow.
Indications for Use
The FDA-cleared indications for the Proxis System Model EPS 101 include use in patients with venous obstructions needing structural support to maintain vein patency. It is suitable for conditions where veins are at risk of collapsing or narrowing.
Practical Considerations
The Proxis System Model EPS 101 is available in various sizes to accommodate different vein diameters, ensuring a proper fit. It is compatible with standard catheter systems used in vascular interventions. Clinicians should be familiar with the deployment technique to ensure optimal placement and performance.
Frequently Asked Questions
What is the Proxis System Model EPS 101 used for?
It is used to maintain or restore patency in veins, particularly in cases of venous obstructions.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients with venous obstructions needing structural support to maintain vein patency.
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.