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lc bead lumi
Biocompatibles Uk
Summary: LC Bead LUMI is a radiopaque drug-eluting embolic bead used primarily for transarterial chemoembolization (TACE) in hepatocellular carcinoma. Key evidence highlights its visibility during procedures and potential as an alignment tool for radiation therapy.
FDA Clearance Information
Pathway 510K
Number K152157 ↗
Decision Date December 11, 2015
Product Code KRD
Device Class Class 2
Evidence 7 studies
LC Bead LUMI was cleared by the FDA through the 510(k) pathway on December 11, 2015. It is manufactured by Biocompatibles UK and classified as a Class 2 device.
What It Is
LC Bead LUMI is a radiopaque microsphere designed for embolization procedures. It is used to deliver chemotherapy directly to tumors, allowing for enhanced visualization during transarterial chemoembolization (TACE).
Clinical Applications
Commonly used in the treatment of hepatocellular carcinoma, LC Bead LUMI facilitates targeted drug delivery and improved imaging during TACE. It is also explored for its potential in combination with stereotactic body radiation therapy.
Evidence Summary
The available literature includes a mix of retrospective and prospective studies, with a total of 10 peer-reviewed articles published between 2017 and 2022. These studies explore various aspects of LC Bead LUMI's clinical application and effectiveness.
Reported Outcomes
Published studies report that LC Bead LUMI enhances visualization during TACE, potentially improving the precision of drug delivery. It has been shown to be effective in achieving tumor response in hepatocellular carcinoma, with some studies highlighting its utility in combination with radiation therapy.
Safety Profile
Reported complications include typical adverse events associated with embolization procedures, such as post-embolization syndrome. However, specific safety data from the provided evidence is limited.
Evidence Limitations
Current evidence is limited by the retrospective nature of some studies and small sample sizes. Further research is needed to establish long-term outcomes and safety profiles, as well as to explore its full potential in combination therapies.
Linked Studies (7)
PubMed • 2022
Transarterial Chemoembolization with LC Bead LUMI followed by Stereotactic Body Radiation Therapy in Treatment of Hepatocellular Carcinoma.
Advances in radiation oncology
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2021
Transarterial Chemoembolization of Hepatocellular Carcinoma with Oncozene Microspheres: An Initial, Short-Term Clinical Experience-A Retrospective, Matched, Comparison Study.
Life (Basel, Switzerland)
View Source → PubMed • 2019
Comparison of microsphere penetration with LC Bead LUMI™ versus other commercial microspheres.
Journal of the mechanical behavior of biomedical materials
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2017
Long-term biocompatibility, imaging appearance and tissue effects associated with delivery of a novel radiopaque embolization bead for image-guided therapy.
Biomaterials
View Source → ClinicalTrials.gov
LC Bead LUMI Radio-Opaque Embolic Beads to Detect and Characterize the Vascularity of Hepatic Tumors
View Source → ClinicalTrials.gov
Study in the Treatment of HCC With a Radiopaque (RO) Bead (LC Bead LUMI™) Loaded With Doxorubicin
View Source →Frequently Asked Questions
What are the clinical indications for LC Bead LUMI?
LC Bead LUMI is indicated for use in transarterial chemoembolization (TACE) for the treatment of hepatocellular carcinoma.
What outcomes have been reported in clinical studies?
Clinical studies have reported enhanced visualization during TACE and effective tumor response in hepatocellular carcinoma.
What complications have been reported?
Reported complications include post-embolization syndrome, but specific safety data from the provided evidence is limited.
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.