LC Bead Microspheres Bead Block Compressible Microspheres
FDA Clearance Information
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
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
Reported Outcomes
Safety Profile
Evidence Limitations
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)
Uterine fibroid embolization with acrylamido polyvinyl microspheres: prospective 12-month clinical and MRI follow-up study.
Acta radiologica (Stockholm, Sweden : 1987)
Prospective View Source →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 →[Role of embolization in the management of uterine fibroids].
Journal de gynecologie, obstetrique et biologie de la reproduction
View Source →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.