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Gelspheres Microspheres and Bead Block Compressible Microspheres
Summary: Gelspheres microspheres and bead block are embolization devices used primarily for tumor treatment and uterine fibroid embolization. Key evidence highlights their role in reducing tumor growth with a focus on safety and efficacy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K042231 ↗
Decision Date ?
November 12, 2004
Product Code ?
HCG Device, Neurovascular Embolization
Device Class ?
Class 2
Evidence ?
4 studies
The device was cleared by the FDA via the 510(k) pathway on November 12, 2004. It is manufactured by Biocompatibles UK and classified as a Class 2 medical device.
What It Is
Gelspheres microspheres and bead block are compressible embolization devices designed to occlude blood vessels. They are used in clinical settings to treat conditions such as tumors and uterine fibroids by blocking blood supply to the targeted area.
FDA-Cleared Indications
- Embolization of blood vessels in the peripheral vasculature.
- Embolization of hypervascular tumors when vascular occlusion is clinically indicated.
- Embolization for uterine fibroids as part of uterine artery embolization.
Clinical Applications
- Uterine artery embolization for symptomatic uterine fibroids.
- Transarterial embolization of selected hypervascular tumors.
- Transarterial chemoembolization of appropriately selected solid tumors when the microspheres are used to occlude tumor-feeding arteries.
- Image-guided embolization of peripheral arteries to reduce blood flow to a targeted tissue.
Reported off-label uses
- Embolization of selected bleeding arteries, depending on the particle size, anatomy and clinical situation.
- Embolization of selected arteriovenous malformations or vascular malformations in specialist practice.
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 literature includes 10 studies ranging from 2017 to 2024, covering various clinical applications of embolization microspheres. Study types include prospective and retrospective analyses, with a focus on safety and efficacy.
Reported Outcomes
Published studies report that gelspheres microspheres and bead block are effective in reducing tumor size and achieving fibroid infarction. They have shown promise in maintaining tumor control while minimizing systemic side effects associated with traditional chemotherapy.
Safety Profile
Reported complications include potential extravasation of microspheres, as observed in preclinical models, and the need to balance safety and efficacy in determining the appropriate size of embolic agents. Overall, the devices are considered safe with manageable risks.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for long-term follow-up studies to fully understand the safety profile. Further research is needed to optimize the size and composition of microspheres for different clinical scenarios.
Practical Considerations
- Particle size should be selected according to the target vessel, desired level of embolization and risk of non-target embolization.
- The microspheres must be prepared and injected according to the product instructions, using compatible catheters and imaging guidance.
- Avoid reflux and confirm the catheter position before injection; embolization of non-target arteries can cause tissue ischemia or infarction.
- MRI considerations depend on the specific product formulation and labeling; the microspheres themselves are not generally metallic, but the complete procedure and any other implanted materials should be reviewed for MRI compatibility.
- Contraindications and precautions include uncorrectable coagulopathy, severe infection in the treatment area, unsuitable vascular anatomy and known hypersensitivity to product components or contrast media.
Linked Studies (4)
PubMed • 2017
Uterine fibroid embolization with acrylamido polyvinyl microspheres: prospective 12-month clinical and MRI follow-up study.
Acta radiologica (Stockholm, Sweden : 1987)
Prospective 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 • 2012
[Role of embolization in the management of uterine fibroids].
Journal de gynecologie, obstetrique et biologie de la reproduction
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 →Frequently Asked Questions
What are the clinical indications for gelspheres microspheres and bead block?
They are indicated for use in embolization procedures for solid tumors and uterine fibroids.
What outcomes have been reported in clinical studies?
Studies have shown effective tumor size reduction and fibroid infarction with these devices.
What complications have been reported?
Safety data indicate potential extravasation and the need for careful selection of microsphere size to balance safety and efficacy.
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.