📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Embolization of selected blood vessels to control or prevent bleeding.
- Embolization to reduce blood flow to tumors.
- Embolization of vascular malformations.
Clinical Applications
- Catheter-based embolization of blood vessels when controlling or preventing bleeding is part of treatment.
- Embolization to reduce the blood supply to a tumor.
- Embolization of a vascular malformation.
- Targeted vessel occlusion performed by an appropriately trained clinician using standard embolization-catheter techniques.
Practical Considerations
- The foam is delivered through a catheter, and the treating clinician selects the catheter and device configuration appropriate for the target vessel.
- Proper positioning is important because unintended embolization can reduce blood flow to healthy tissue.
- Patient-specific contraindications, including allergy or intolerance to device components and an unsuitable vascular route, should be assessed before treatment.
- MRI safety and scanning conditions should be confirmed in the current manufacturer labeling before an MRI examination; this record does not establish that the device is MR Safe or MR Conditional.
- Use requires clinicians trained in angiography, catheter navigation, embolization, and management of possible ischemic or bleeding complications.
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.