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gelspheres microspheres and bead block compressible microspheres
Biocompatibles Uk
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
510K
Number
K042231 ↗
Decision Date
November 12, 2004
Product Code
HCG
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.
Clinical Applications
These devices are commonly used in interventional radiology for procedures like transarterial chemoembolization (TACE) in solid tumors and uterine fibroid embolization (UFE). They provide a minimally invasive option for reducing blood flow to pathological tissues.
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.
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.