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lava r liquid embolic system lava les
Sirtex Medical
Summary: The Lava R Liquid Embolic System is a medical device used for embolization procedures, primarily by interventional radiologists and neurosurgeons. It is designed to occlude blood vessels in various clinical scenarios.
FDA Clearance Information
Pathway
PMA
Number
P220020 ↗
Decision Date
October 26, 2023
Product Code
QVG
Device Class
Class 3
Evidence
0 studies
The Lava R Liquid Embolic System, manufactured by Sirtex Medical, received FDA clearance via the PMA pathway on October 26, 2023. It is classified as a Class 3 device under product code QVG.
What It Is
The Lava R Liquid Embolic System is a liquid embolic agent used to block blood flow in targeted blood vessels. It works by being injected into the vasculature where it solidifies, effectively occluding the vessel. This device is particularly useful in controlling bleeding or reducing blood supply to tumors.
Clinical Applications
This device is commonly used in interventional radiology and neurosurgery for procedures such as treating arteriovenous malformations (AVMs) or pre-surgical tumor embolization. It is suitable for use in both hospital and outpatient settings, and is typically employed in adult patients requiring vascular occlusion.
Indications for Use
The FDA indications suggest that the Lava R Liquid Embolic System is used for occluding blood vessels in cases where controlling blood flow is necessary, such as in vascular malformations or tumor management.
Practical Considerations
The Lava R Liquid Embolic System comes in various viscosities to accommodate different vessel sizes and flow dynamics. It is compatible with standard microcatheters and requires careful handling to ensure precise delivery and effective embolization.
Frequently Asked Questions
What is Lava R Liquid Embolic System used for?
It is used for embolization procedures to occlude blood vessels, often in cases of vascular malformations or to reduce blood supply to tumors.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use this device for embolization procedures.
What are the FDA-cleared indications?
The device is indicated for use in occluding blood vessels to control blood flow in various clinical scenarios, such as vascular malformations or tumor management.
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.