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LC Bead Lumi
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 ?
510(k)
Number ?
K162373 ↗
Decision Date ?
December 16, 2016
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 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.
FDA-Cleared Indications
- Embolization of blood vessels in the peripheral vasculature.
- Use as an embolic material for transarterial chemoembolization procedures.
- The FDA clearance applies to the device category identified by product code KRD; specific clinical uses must follow the current device labeling.
Clinical Applications
- Transarterial chemoembolization for hepatocellular carcinoma when consistent with the product labeling and treatment plan.
- Delivery of chemotherapy to selected arteries supplying a liver tumor while reducing arterial blood flow.
- Radiopaque embolization during image-guided peripheral vascular procedures where visualization of the embolic material is clinically useful.
Reported off-label uses
- Embolization of selected hypervascular tumors other than hepatocellular carcinoma.
- Embolization for control of bleeding or reduction of blood flow in selected peripheral vascular conditions.
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 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.
Practical Considerations
- The beads are available in different size ranges; the selected size depends on the target vessel, tumor vascularity, treatment goal, and microcatheter compatibility.
- They are delivered through a catheter under fluoroscopic or other X-ray guidance and should be prepared and administered according to the current instructions for use.
- Radiopacity can help confirm bead distribution, but angiography and clinical monitoring remain necessary to assess blood flow and non-target embolization.
- Potential risks include pain, fever, infection, bleeding, vessel injury, non-target embolization, and ischemic injury to normal tissue; liver-directed treatment may also cause post-embolization syndrome or worsening liver function.
- MRI compatibility and any imaging-related restrictions should be confirmed in the current manufacturer labeling; the embolization procedure itself may involve iodinated contrast and is not appropriate for every patient.
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.