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vivorte trabexus eb
Vivorte
Summary: The Vivorte Trabexus EB is a medical device used in embolization procedures, primarily by interventional radiologists. It is designed to occlude blood vessels in various clinical scenarios.
FDA Clearance Information
Pathway
510K
Number
K143547 ↗
Decision Date
January 14, 2015
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
The Vivorte Trabexus EB was cleared through the FDA 510(k) pathway on January 14, 2015. It is manufactured by Vivorte and classified as a Class 2 device under product code MBP.
What It Is
The Vivorte Trabexus EB is an embolization microsphere device. It is used to occlude blood vessels, typically in procedures to treat hypervascular tumors or arteriovenous malformations. The device works by being delivered through a catheter to the target site, where it blocks blood flow to specific areas, aiding in therapeutic interventions.
Clinical Applications
This device is commonly used in interventional radiology settings. It is employed in procedures such as uterine fibroid embolization, treatment of liver tumors, and management of gastrointestinal bleeding. The device is suitable for adult patients requiring targeted embolization to manage or treat specific vascular conditions.
Indications for Use
The FDA indications for the Vivorte Trabexus EB include its use in embolization procedures to occlude blood vessels. It is intended for patients with conditions like hypervascular tumors or arteriovenous malformations where blood flow needs to be controlled.
Practical Considerations
Clinicians should consider the size of the microspheres and the compatibility with the catheter system used. Proper technique in delivery is crucial to ensure effective embolization and minimize complications. Training in interventional procedures is recommended for optimal use.
Frequently Asked Questions
What is Vivorte Trabexus EB used for?
The device is used for embolization procedures to occlude blood vessels in conditions such as hypervascular tumors and arteriovenous malformations.
What specialties typically use this device?
Interventional radiologists primarily use this device in procedures requiring vascular occlusion.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to occlude blood vessels in patients with conditions like hypervascular tumors.
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.