Product Information


Building on the confidence seen with LC Bead®:

  • Market-leading embolic bead.
  • >30 peer-reviewed clinical publications.
  • Established therapy in US for over 10 years.
 

Evolving the unique chemistry: from LC Bead® to LC Bead LUMI

Innovative incorporation of a tri-iodobenzl moiety in LC Bead LUMIoffers:1

  • Inherent, long-term radiopacity.
  • Even after contrast wash-out.

All without compromising the proven performance of LC Bead®

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LC Bead LUMI: consistent visibility every time

Iodine is evenly distributed throughout every bead — ensures consistent radiopacity every time1.

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LC Bead LUMI: Vision. Precision. Assurance.

LC Bead LUMI is a next-generation development of LC Bead® that provides every time:

  1. VISION 

    Real-time visible confirmation of bead location during embolization, visible in all standard X-ray imaging modalities and in follow-up scans due to long-lasting radiopacity.

  2. PRECISION

    The potential to provide increased control by enabling real-time adjustments and enhanced determination of embolization endpoints, therefore optimized.

  3. ASSURANCE

    Allowing precise evaluation and confident reporting of the completeness of treatment and informing decisions for future management.

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Image courtesy NIH with permission*

 

LC Bead LUMI indication

LC Bead LUMI are intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).

 

Delivery of LC Bead LUMI

LC Bead LUMI are delivered in commonly used contrast agents without dilution and may be delivered through routinely-used microcatheters.

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Cautions

  • Embolization with LC Bead LUMI should only be performed by physicians who have received appropriate interventional occlusion training in the anatomical region intended to be embolized.
  • Do not use if the vial or packaging appears damaged.
  • Sterile and single-use product. Do not reuse due to risk of infection.
  • If there are any symptoms of unwanted embolization during injection, consider stopping the procedure to evaluate the possibility of shunting. Such symptoms may include changes in patient’s vital signs, such as hypoxia or central nervous system changes.
  • In case of hypersensitivity to contrast agents it is recommended not to use LC Bead LUMI.
  • Consider upsizing LC Bead LUMI in the presence of AV shunts if angiographic evidence of embolization does not appear quickly during delivery.
  • Use only the recommended non-ionic contrast agents.
  • Non-target embolization may occur in the presence of arteriovenous anastomosis, branch vessels which lead away from the targeted embolization area, or emergent vessels not evident prior to embolization. The patient may experience severe complications as a result of nontarget embolization. Special care should be taken to avoid ischemia of non-tolerant, non-targeted tissue.
  • Patients with prior biliary surgery, bile duct dilation or vessels close to bile ducts may be at increased risk from infection (e.g. biloma/ liver abscess).
  • Consideration should be given to Tc99m-MAA scanning if there is suspicion of AV shunting.
  • Risks of radiation from angiography and fluoroscopy used to visualize the blood vessels during embolization which may include a radiation burn and risks to future fertility.
  • A maximum of 4 vials of LC Bead LUMI can be used in a single treatment session.

Access the LC Bead LUMI instruction for use at: lcbeadlumi.com/ifu.aspx

 

Potential complications

  • Undesirable reflux or passage of LC Bead LUMI into normal arteries adjacent to the targeted lesion or through the lesion into other arteries or arterial beds, such as the pulmonary, internal carotid or coronary circulations.
    • Non-target embolization for example:
      • Pulmonary embolization.
      • Pancreatitis.
  • Deep vein thrombosis, or clotting of a deep vein in patient’s leg(s).
  • Thrombosis of the artery at the incision site for arterial access.
  • Ischemia at an undesirable location.
  • Capillary bed saturation and tissue damage.
  • Ischemic stroke or ischemic infarction.
  • Vessel or lesion/tumor rupture and hemorrhage.
  • Neurological deficits including cranial nerve palsies.
  • Vasospasm.
  • Recanalization.
  • Foreign body reactions necessitating medical intervention.
  • Infection necessitating medical intervention.
  • Clot formation at the tip of the catheter and subsequent dislodgement causing arterial thromboembolic sequelae.
  • Post embolization syndrome which may include nausea, fever, pain and increases in laboratory parameters such as elevated liver enzymes.
  • Allergic reactions when used in conjunction with contrast agents in patients who are allergic or intolerant to those contrast agents.
  • Embolization of the wrong artery or migration of the beads to other parts of the body, which may necessitate further treatment.
  • Hematoma, or bruising or arterial aneurysm, at the arterial access incision site.
  • Liver abscess.
  • Death.


CAUTION: Federal (USA) law restricts this device to sale by or on order of a physician.


Reference
*Images courtesy NIH with permission. Any reference to NIH or the authors should not be viewed as an endorsement of BTG, its products or services.
1. Duran R, et al. Theranostics 2016;6:28–38.