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artline
Health Line International
Summary: The artline is a Class 2 medical device used in venous stenting procedures. It is primarily utilized by vascular surgeons and interventional radiologists to support vein patency.
FDA Clearance Information
Pathway
510K
Number
K160448 ↗
Decision Date
July 12, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The artline device by Health Line International was cleared through the FDA 510k pathway on July 12, 2016. It is classified as a Class 2 device under product code DQY.
What It Is
The artline is a venous stent designed to maintain or restore blood flow in veins. It is typically used in procedures to treat venous obstructions or insufficiencies. The device is inserted into the affected vein, where it expands to provide structural support and improve circulation.
Clinical Applications
The artline is commonly used in procedures addressing chronic venous insufficiency or post-thrombotic syndrome. It is often employed in hospital settings, particularly in vascular surgery and interventional radiology departments. The device is suitable for adult patients experiencing venous blockages or requiring vein support.
Indications for Use
The artline is indicated for use in patients with venous obstructions that require stenting to maintain blood flow. It is particularly useful in cases where veins have become narrowed or blocked, necessitating intervention to prevent complications.
Practical Considerations
The artline comes in various sizes to accommodate different vein diameters. It is compatible with standard delivery systems used in venous interventions. Clinicians should ensure proper sizing and placement technique to optimize outcomes and minimize complications.
Related Literature
The linked study investigated the effectiveness of different markers for preoperative vein mapping through ultrasound coupling gel. It found that certain markers, including the 'Artline 70', performed well in maintaining visibility after gel removal. While the study provides useful insights for preoperative planning, its relevance to the artline device is limited as it focuses on marking techniques rather than stent performance.
Frequently Asked Questions
What is artline used for?
The artline is used for maintaining or restoring blood flow in veins by providing structural support in cases of venous obstruction.
What specialties typically use this device?
Vascular surgeons and interventional radiologists commonly use the artline in venous stenting procedures.
What are the FDA-cleared indications?
The artline is indicated for use in treating venous obstructions to maintain or restore 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.