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embogold microsphere
Biosphere Medical
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
510K
Number
K010026 ↗
Decision Date
June 21, 2001
Product Code
HCG
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.
Clinical Applications
Common clinical scenarios for Embogold Microsphere include the treatment of uterine fibroids and other hypervascular tumors. It is used in interventional radiology to achieve targeted embolization.
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.
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.