📊 Evidence-Based Reference

LC Bead Microspheres Bead Block Compressible Microspheres

Biocompatibles Uk Ltd

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Summary: LC Bead Microspheres are embolization devices used primarily for treating hepatocellular carcinoma. Key evidence includes randomized trials comparing embolization techniques.

FDA Clearance Information

Pathway ? 510(k)
Number ? K083091 ↗
Decision Date ? December 24, 2008
Product Code ? KRD Device, Vascular, For Promoting Embolization
Device Class ? Class 2
Evidence ? 4 studies

The LC Bead Microspheres received FDA clearance through the 510(k) pathway on December 24, 2008. Manufactured by Biocompatibles UK, they are classified as Class II devices.

What It Is

LC Bead Microspheres are compressible microspheres used in embolization procedures. They are designed to occlude blood vessels, primarily in the treatment of liver tumors such as hepatocellular carcinoma.

FDA-Cleared Indications

  • Embolization of blood vessels when vascular occlusion is clinically indicated.
  • Use as an embolic agent in transarterial procedures for selected liver tumors, including hepatocellular carcinoma, according to the applicable product labeling.

Clinical Applications

  • Transarterial embolization of selected unresectable hepatocellular carcinomas.
  • Embolization of tumor-feeding arteries in the liver.
  • Standalone embolization to reduce or stop blood flow to a target lesion.
  • Delivery of chemotherapy during transarterial chemoembolization when used with an appropriate drug and under the applicable labeling.

Reported off-label uses

  • Embolization of other hypervascular liver tumors or metastases.
  • Embolization of selected extrahepatic tumors or vascular malformations when clinically appropriate.
  • Treatment of selected bleeding or vascular-flow conditions using microsphere embolization techniques.

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 randomized controlled trials and other study types, with a focus on embolization for liver cancer. Studies date from 2016 to 2017, highlighting comparisons between embolization techniques.

Reported Outcomes

Published studies report that LC Bead Microspheres are effective in occluding blood vessels in liver tumors. Comparisons with drug-eluting beads suggest similar efficacy in tumor response rates.

Safety Profile

Reported complications include potential exposure risks to healthcare workers from drug residues. However, specific adverse events related to the device itself are not detailed in the provided evidence.

Evidence Limitations

The evidence is limited by a lack of detailed safety outcomes and long-term efficacy data. Further research is needed to establish comprehensive safety profiles and comparative effectiveness.

Practical Considerations

  • Microsphere size selection depends on the target vessel, tumor vascularity, desired level of occlusion, and risk of non-target embolization.
  • The beads are delivered through a compatible angiographic catheter under fluoroscopic or other appropriate imaging guidance; catheter size and embolic compatibility must be confirmed before use.
  • Proper suspension and gentle handling are important because aggregation, settling, or excessive compression can affect delivery.
  • Contraindications and precautions include uncontrolled infection, non-target arterial pathways, significant uncorrectable coagulopathy, and hypersensitivity to the product or its components, according to the current instructions for use.
  • MRI safety and conditional use depend on the complete treated system, including any radiopaque markers, coils, stents, catheters, or drug components; review the current manufacturer labeling and the patient's other implanted devices.

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, particularly in the treatment of hepatocellular carcinoma.

What outcomes have been reported in clinical studies?

Clinical studies have reported effective vessel occlusion and comparable tumor response rates to other embolization techniques.

What complications have been reported?

Safety data from the evidence indicate potential contamination risks for healthcare workers, but specific device-related adverse events are not detailed.

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.

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