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artix ballon guiding sheath
Inari Medical
Summary: The Artix Balloon Guiding Sheath is a medical device used in vascular procedures, primarily by interventional radiologists and cardiologists. It is designed to assist in the placement and guidance of venous stents.
FDA Clearance Information
Pathway
510K
Number
K221846 ↗
Decision Date
July 11, 2022
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Artix Balloon Guiding Sheath by Inari Medical was cleared through the FDA 510k pathway on July 11, 2022. It is classified as a Class 2 device under product code DQY.
What It Is
The Artix Balloon Guiding Sheath is a specialized catheter designed to facilitate the placement of venous stents. It features an inflatable balloon that helps stabilize the sheath within the vessel, providing a stable platform for stent deployment. This device is particularly useful in procedures involving the venous system, where precise placement and guidance are crucial.
Clinical Applications
The Artix Balloon Guiding Sheath is commonly used in interventional radiology and cardiology settings for procedures involving venous stenting. It is particularly useful in treating conditions such as deep vein thrombosis (DVT) or chronic venous insufficiency, where stent placement can help restore proper blood flow. The device is typically used in hospital settings, catering to adult patients with venous obstructions.
Indications for Use
The FDA has cleared the Artix Balloon Guiding Sheath for use in procedures requiring venous stent placement. It is indicated for patients with conditions like venous obstructions or thrombosis, where stenting can improve vascular patency.
Practical Considerations
The Artix Balloon Guiding Sheath is available in various sizes to accommodate different vessel diameters. It is compatible with standard stent delivery systems and requires careful handling to ensure proper balloon inflation and deflation. Clinicians should be familiar with the device's inflation mechanism to optimize procedural outcomes.
Frequently Asked Questions
What is the Artix Balloon Guiding Sheath used for?
It is used to assist in the placement and guidance of venous stents during vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stent placement, particularly for patients with venous obstructions or thrombosis.
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.