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vivorte bvf
Vivorte
Summary: The Vivorte BVF 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 K130703 ↗
Decision Date September 12, 2013
Product Code MBP
Device Class Class 2
Evidence 0 studies
The Vivorte BVF was cleared through the FDA 510k pathway on September 12, 2013. Manufactured by Vivorte, it is classified as a Class 2 device under product code MBP.
What It Is
The Vivorte BVF is a bioactive vitreous foam used in embolization procedures. It works by occluding blood vessels to stop or reduce blood flow to a targeted area, which can be useful in treating conditions such as tumors or vascular malformations. The device is designed to be delivered via catheter, allowing for precise placement in the vasculature.
Clinical Applications
This device is commonly used in interventional radiology for procedures such as uterine fibroid embolization, treatment of arteriovenous malformations, and pre-operative embolization of hypervascular tumors. It is typically used in hospital settings, particularly in the interventional suite, and is suitable for adult patients requiring targeted vessel occlusion.
Indications for Use
The FDA-cleared indications for the Vivorte BVF include embolization of blood vessels to control or prevent bleeding, reduce blood supply to tumors, or treat vascular malformations. It is intended for patients who require such interventions as part of their treatment plan.
Practical Considerations
The Vivorte BVF is available in various sizes to accommodate different vessel diameters. It is compatible with standard embolization catheters, and clinicians should be trained in catheter-based techniques to ensure proper deployment and positioning of the device.
Frequently Asked Questions
What is Vivorte BVF used for?
The Vivorte BVF is used for embolization procedures to occlude blood vessels, often to control bleeding or reduce blood supply to tumors.
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 embolization to control bleeding, reduce tumor blood supply, or treat vascular malformations.
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.