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LC Bead Lumi
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 ?
510(k)
Number ?
K152157 ↗
Decision Date ?
December 11, 2015
Product Code ?
KRD Device, Vascular, For Promoting Embolization
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).
FDA-Cleared Indications
- Embolization of blood vessels when blocking or reducing blood flow is clinically indicated.
- Use as an embolic material during image-guided vascular procedures.
- Radiopaque visualization of the embolic material during and after delivery.
Clinical Applications
- Image-guided embolization of selected tumor-feeding arteries.
- Transarterial chemoembolization (TACE) when the device, chemotherapy regimen and procedure are used according to applicable labeling.
- Radiopaque embolization where visualization of bead location is clinically useful.
Reported off-label uses
- Embolization of hypervascular tumors outside the labeled indication.
- Use as a radiopaque marker to support treatment planning or alignment for radiation therapy.
- Embolization in other vascular territories using techniques established for comparable embolic microspheres.
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 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.
Practical Considerations
- The device is available in different microsphere size ranges; selection depends on the target vessel, desired level of occlusion and treatment objective.
- Delivery requires a compatible microcatheter and careful suspension and handling according to the instructions for use. Beads should be injected under fluoroscopic or other appropriate imaging guidance.
- Do not inject against excessive resistance. Reflux, non-target embolization and unintended vessel occlusion are important procedural risks.
- MRI safety and artifact information should be confirmed in the current manufacturer labeling before MRI. Radiopaque beads may affect imaging interpretation.
- Contraindications, medication-loading requirements, preparation steps and compatibility with chemotherapy agents must be checked in the current instructions for use.
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.