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.
Clinical Applications
Commonly used in transarterial embolization procedures, LC Bead Microspheres are employed in the management of unresectable liver cancer. They serve as a vehicle for drug delivery or as standalone embolic agents.
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.
Linked Studies (4)
PubMed • 2017
Uterine fibroid embolization with acrylamido polyvinyl microspheres: prospective 12-month clinical and MRI follow-up study.
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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