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Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization
Summary: Embosphere and Embogold microspheres are used in uterine fibroid embolization. They are FDA-cleared devices with evidence supporting their use in embolization procedures. Key studies focus on their mechanical and biological properties.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K021397 ↗
Decision Date ?
November 22, 2002
Product Code ?
NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
Device Class ?
Class 2
Evidence ?
16 studies
The Embosphere and Embogold microspheres were cleared by the FDA via the 510(k) pathway on November 22, 2002. Manufactured by Biosphere Medical, these devices are classified as Class 2 medical devices.
What It Is
Embosphere and Embogold microspheres are embolic agents used in uterine fibroid embolization. They consist of acrylic polyamide plastic particles designed to occlude blood vessels, thereby reducing blood flow to targeted areas.
FDA-Cleared Indications
- Uterine fibroid embolization to reduce blood flow to symptomatic uterine fibroids.
Clinical Applications
- Embolization of uterine arteries supplying symptomatic uterine fibroids.
- Treatment of uterine fibroids using image-guided transcatheter embolization.
Reported off-label uses
- Embolization for selected hypervascular tumors or bleeding sites may be reported in clinical practice, but these applications are outside the stated uterine fibroid indication and require case-specific physician judgment.
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 two studies from 2007 that evaluate the mechanical and biological characteristics of these microspheres. These studies provide insights into their performance in vitro and in human tissue.
Reported Outcomes
Published studies report that Embosphere and Embogold microspheres demonstrate effective size distribution and compressive strength suitable for embolization procedures. The studies highlight their utility in achieving desired embolic effects in clinical settings.
Safety Profile
Reported complications include potential issues related to the mechanical properties of the microspheres, although specific adverse events are not detailed in the provided studies. Further safety data is needed to comprehensively assess risks.
Evidence Limitations
The evidence is limited to in vitro evaluations and lacks extensive clinical trial data. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Practical Considerations
- The microspheres are available in different particle-size ranges; the selected size depends on the target vessels, blood flow, and desired level of occlusion.
- They are delivered through a compatible catheter under fluoroscopic or other image guidance, usually through arterial access in the groin or wrist.
- The particles must be prepared and injected according to the product labeling to reduce aggregation, reflux, or non-target embolization.
- Contraindications and precautions include pregnancy, active pelvic infection, suspected pelvic malignancy, severe contrast allergy or kidney disease, and vascular anatomy that cannot be safely catheterized; the treating team evaluates each patient.
- The particles are intended to remain in the treated vessels and are not removed after embolization. MRI considerations depend on the complete embolization system and should be confirmed in current labeling; the microspheres themselves are nonmetallic.
Linked Studies (16)
PubMed • 2025
Multicenter, PrOspective, Randomized, Controlled Trial Comparing GenIcular Artery EmbOlization Using Embosphere Microspheres to Corticosteroid iNjections for the Treatment of Symptomatic Knee Osteoarthritis: MOTION Study Protocol Summary.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Uterine artery embolization in sheep: comparison of acute effects with Embosphere microspheres and Embosoft microspheres.
Acta radiologica (Stockholm, Sweden : 1987)
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparison of the Efficacy of Polyvinyl Alcohol Colorless Embolic Microspheres (8Spheres) and Gelatin Embolic Microspheres (Embosphere) in Uterine Artery Embolization for Symptomatic Uterine Fibroids in Women Without Fertility Requirements: A Multicenter Observational Study.
International journal of women's health
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Embosphere microspheres size for bronchial artery embolization in patients with hemoptysis caused by bronchiectasis: a retrospective comparative analysis of 500-750 versus 700-900 μm microspheres.
BMC pulmonary medicine
Retrospective View Source →PubMed • 2023
Two-year outcomes comparing Embosphere® microspheres versus Imipenem Cilastatin for genicular artery embolization in patients with moderate to severe knee osteoarthritis.
The Knee
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Clinical Study on the Treatment of Benign Prostatic Hyperplasia by Embolization of Prostate Artery Based on Embosphere Microspheres and Gelatin Sponge Granules.
Journal of healthcare engineering
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Embolization of Skull Base Meningiomas with Embosphere Microspheres: Factors Predicting Treatment Response and Evaluation of Complications.
World neurosurgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2021
Investigation of the Physical Properties and Clinical Application of Embosphere Microspheres.
Chemotherapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2020
Comparison of the Efficacy of Two Microsphere Embolic Agents for Transcatheter Arterial Chemoembolization in Hepatocellular Carcinoma Patients.
Cancer research and treatment
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2017
Prostatic Artery Embolization Using Embosphere Microspheres for Prostates Measuring 80-150 cm(3): Early Results from a US Trial.
Journal of vascular and interventional radiology : JVIR
View Source →PubMed • 2012
Comparison of clinical and MR imaging outcomes after uterine fibroid embolization with Bead Block and Embosphere.
European journal of radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2011
The arterial distribution of Embozene and Embosphere microspheres in sheep kidney and uterus embolization models.
Journal of vascular and interventional radiology : JVIR
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2009
Experimental liver embolization with four different spherical embolic materials: impact on inflammatory tissue and foreign body reaction.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2005
Preoperative embolization of intracranial meningiomas with Embosphere microspheres.
Minimally invasive neurosurgery : MIN
RCT|prospective|retrospective|case Series|other View Source →ClinicalTrials.gov
A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
View Source →Frequently Asked Questions
What are the clinical indications for Embosphere and Embogold microspheres?
These microspheres are indicated for use in uterine fibroid embolization and other vascular embolization procedures.
What outcomes have been reported in clinical studies?
Studies report effective size distribution and compressive strength, supporting their use in embolization procedures.
What complications have been reported?
Reported complications include potential mechanical issues, but specific adverse events are not detailed in the provided studies.
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.