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LC Bead Microspheres Bead Block Compressible Microspheres
Summary: LC Bead Microspheres are embolization devices used primarily for treating hepatocellular carcinoma. Key evidence includes a randomized trial comparing embolization with and without doxorubicin.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K094018 ↗
Decision Date ?
April 16, 2010
Product Code ?
HCG Device, Neurovascular Embolization
Device Class ?
Class 2
Evidence ?
4 studies
The LC Bead Microspheres by Biocompatibles UK were cleared via the FDA 510(k) pathway on April 16, 2010. They are classified as Class 2 devices under product code HCG.
What It Is
LC Bead Microspheres are compressible embolization devices designed to occlude blood vessels. They are primarily used in transarterial embolization procedures for treating liver tumors.
FDA-Cleared Indications
- Embolization of blood vessels in the peripheral vasculature.
- Use in transarterial embolization procedures when selective vascular occlusion is required.
- The device is cleared as a Class II embolization device under FDA product code HCG, Device, Neurovascular Embolization.
Clinical Applications
- Transarterial embolization of hepatocellular carcinoma when tumor blood supply is targeted.
- Embolization of selected hepatic arteries supplying liver tumors.
- Vascular occlusion during image-guided embolization procedures in the peripheral vasculature.
Reported off-label uses
- Embolization of hypervascular metastatic tumors in the liver.
- Treatment of symptomatic uterine fibroids by uterine artery embolization.
- Embolization of selected bleeding vessels or arteriovenous malformations, depending on anatomy and device labeling.
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 four studies, with types ranging from randomized controlled trials to other observational designs. The studies span from 2016 to 2017, focusing on embolization techniques and outcomes.
Reported Outcomes
Published studies report that embolization using LC Bead Microspheres can effectively reduce tumor size in hepatocellular carcinoma. A randomized trial indicated no clear superiority of doxorubicin-eluting beads over non-drug-eluting beads in terms of overall survival.
Safety Profile
Reported complications include potential risks associated with embolization procedures, such as post-embolization syndrome and non-target embolization. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of long-term follow-up data. Further research is needed to clarify the comparative effectiveness of drug-eluting versus non-drug-eluting microspheres.
Practical Considerations
- Microspheres are available in calibrated size ranges; the selected size depends on the target vessel, desired level of occlusion, and arteriovenous anatomy.
- The particles are delivered through a compatible catheter under fluoroscopic imaging. They should not be injected into vessels supplying the brain, spinal cord, or other unintended organs.
- The product may be prepared in contrast-containing suspension to permit fluoroscopic visualization and controlled delivery.
- Contraindications and precautions include non-target embolization risk, uncorrectable coagulopathy, severe vascular tortuosity, infection in the treatment area, and inability to safely catheterize the target vessel.
- MRI safety depends on the specific product configuration and labeling; the device and any delivery accessories should be checked in the current manufacturer instructions before MRI.
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 LC Bead Microspheres?
LC Bead Microspheres are indicated for use in embolization procedures to treat hepatocellular carcinoma and other hypervascular tumors.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective tumor size reduction with LC Bead Microspheres, though no significant survival advantage was found over drug-eluting beads.
What complications have been reported?
Safety data indicate risks such as post-embolization syndrome and non-target embolization, typical of embolization procedures.
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.