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Embogold Microsphere
Summary: Embogold Microsphere is a medical device used for embolization procedures. It is primarily used to treat tumors and vascular lesions. Key evidence includes studies on its mechanical and biological characteristics.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K010026 ↗
Decision Date ?
June 21, 2001
Product Code ?
HCG Device, Neurovascular Embolization
Device Class ?
Class 2
Evidence ?
0 studies
Embogold Microsphere was cleared by the FDA through the 510(k) pathway on June 21, 2001. It is manufactured by Biosphere Medical and classified as a Class 2 device.
What It Is
Embogold Microsphere is a device composed of microspheres used in embolization procedures. It is designed to occlude blood vessels, thereby reducing blood flow to targeted areas such as tumors or vascular lesions.
FDA-Cleared Indications
- Embolization of blood vessels when temporary or permanent vascular occlusion is clinically indicated, consistent with the device labeling.
- Use as a neurovascular embolization device under FDA product code HCG and classification 21 CFR 882.5950.
Clinical Applications
- Catheter-directed embolization of selected blood vessels.
- Reduction of blood flow to a targeted vascular territory.
- Embolization of hypervascular lesions when the procedure is consistent with the device's cleared labeling.
Reported off-label uses
- Uterine fibroid embolization has been described for microsphere embolic agents, but the specific FDA labeling for this device should be confirmed before use.
- Embolization of selected hypervascular tumors and vascular malformations has been reported for microsphere embolic agents; these applications may be off-label for this device.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes five studies, ranging from case series to comparative evaluations, published between 2002 and 2019. These studies explore the device's mechanical properties and clinical applications.
Reported Outcomes
Published studies report that Embogold Microsphere is effective in achieving embolization in various clinical settings. Comparative evaluations indicate similar size distributions and compressive forces among different embolic agents. The device has been used successfully in uterine artery embolization for leiomyomas.
Safety Profile
Reported complications include foreign body granulomas following cervico-facial arterial embolization. Safety assessments in studies did not identify significant adverse events, but further monitoring is suggested.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to fully understand long-term outcomes and potential complications.
Practical Considerations
- Particle size selection should match the target vessel size, desired level of occlusion, and risk of non-target embolization.
- The spheres must be prepared and delivered through a compatible catheter using appropriate suspension and mixing technique.
- Embolization requires angiographic imaging to confirm target-vessel anatomy, flow, and treatment endpoint.
- Do not assume MRI safety from the product name alone; confirm the current device labeling and MRI conditions with the manufacturer.
- Contraindications and precautions include uncontrolled infection, unacceptable risk of non-target embolization, unsuitable vascular access, and allergy or intolerance to procedure-related materials.
Frequently Asked Questions
What are the clinical indications for Embogold Microsphere?
Embogold Microsphere is indicated for the embolization of hypervascular tumors and vascular lesions.
What outcomes have been reported in clinical studies?
Studies report effective embolization and similar mechanical properties compared to other embolic agents.
What complications have been reported?
Reported complications include foreign body granulomas in some cases of cervico-facial arterial embolization.
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.