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lc bead lumi
Biocompatibles Uk
Summary: LC Bead LUMI is a radiopaque drug-eluting bead used in transarterial chemoembolization (TACE) for hepatocellular carcinoma. Key evidence highlights its visibility during procedures and potential for improved drug delivery.
FDA Clearance Information
Pathway
510K
Number
K162373 ↗
Decision Date
December 16, 2016
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 16, 2016. Manufactured by Biocompatibles UK, it is classified as a Class 2 device.
What It Is
LC Bead LUMI is a radiopaque embolization microsphere designed for use in transarterial chemoembolization (TACE). It allows for enhanced visualization during procedures, facilitating precise delivery of chemotherapeutic agents to tumors.
Clinical Applications
Commonly used in the treatment of hepatocellular carcinoma, LC Bead LUMI is employed during TACE to deliver chemotherapy directly to liver tumors. Its radiopacity aids in real-time imaging and accurate placement.
Evidence Summary
The available literature includes 10 studies, comprising retrospective and case series designs, published between 2017 and 2022. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that LC Bead LUMI enhances visualization during TACE, potentially improving the accuracy of drug delivery. Some studies indicate favorable tumor response rates in hepatocellular carcinoma patients.
Safety Profile
Reported complications include typical embolization-related events such as post-embolization syndrome. No unique safety concerns specific to LC Bead LUMI were highlighted in the reviewed studies.
Evidence Limitations
The evidence is primarily retrospective and case series in nature, which may limit the generalizability of findings. Further prospective studies are needed to confirm long-term efficacy and safety.
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 potential improvements in tumor response rates.
What complications have been reported?
Reported complications include post-embolization syndrome, which is common in 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.