Instructions for Use

Sterile • Single-Use Only • Non-Pyrogenic • Latex-Free


Description:

LC Bead LUMI are precisely calibrated, radiopaque, biocompatible, non-resorbable hydrogel beads. The beads are produced from polyvinyl alcohol and contain a covalently bound radiopaque moiety.
LC Bead LUMI™ are manufactured to be inherently radiopaque and visible under imaging (Computed Tomography [CT], Cone Beam Computed Tomography [CBCT] and Fluoroscopy).

Size Label Color
70 - 150 µm Black
100 - 300 µm Yellow


Presentation:

  • LC Bead LUMI™ are offered in a prefilled 10ml glass vial, stopper-sealed by an aluminium cap with a color-coded lid.
  • Each vial contains approximately 2ml of product in sterile phosphate buffered saline. The total volume of LC Bead LUMI™ and sterile physiological saline is approximately 8ml.
  • Each package contains a sterile 20mm ViaLok™ Vented Vial Access Device (Yukon Medical LLC, 4021 Stirrup Creek, Durham, NC USA) for removal of LC Bead LUMI™ from the vial.
  • Each vial of LC Bead LUMI™ is intended for single patient use only. Do not re-sterilize. Discard any unused material.
 

Indication:

LC Bead LUMI is intended to be used for the embolization of hypervascular tumors and arteriovenous malformations.


Contraindications:

  • Patients intolerant to occlusion procedures.
  • Vascular anatomy or blood flow that precludes catheter placement or injection of embolics.
  • Presence or likely onset of vasospasm.
  • Presence or likely onset of hemorrhage.
  • Presence of severe atheromatous disease.
  • Lesion/tumor-feeding vessel with diameter smaller than any distal vessel(s) branching from it.
  • Presence of patent extra-to-intracranial anastomoses or shunts.
  • Presence of end arteries leading directly to cranial nerves.
  • Presence of arteries supplying the lesion/tumor not large enough to accept
    LC Bead LUMI™.
  • Vascular resistance peripheral to the feeding arteries precluding passage of
    LC Bead LUMI™ into the lesion/tumor.
  • Presence of collateral vessel pathways potentially endangering normal territories during the embolization procedure that cannot be coiled or blocked.
  • Presence of high-flow arteriovenous shunt with a diameter greater than the selected bead size that cannot be coiled or blocked.
  • Do not use LC Bead LUMI in the following applications:
    • Embolization of arteriovenous (AV) shunts (i.e. where the blood does not pass through the arterial/capillary/venous transition but directly from artery to vein).
    • Any vasculature where LC Bead LUMI could pass directly into the internal carotid artery or other non-target territories.
    • Any neurovascular indication.
  • Do not use in the pulmonary arterial vasculature.


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.


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.


Delivery instructions:

Note: Please note that LC Bead LUMI will settle quickly in some contrast agents. Prior to and during delivery, ensure that the beads are in suspension. Please note that larger beads have shorter suspension times than the smaller size ranges of LC Bead LUMI.

  1. Using standard techniques, position the delivery catheter within the target vessel and the catheter tip as close as possible to the treatment site to avoid inadvertent occlusion of non-target vessels.
  2. Use a 3ml syringe to manage the injection pressure during catheter delivery of the
    LC Bead LUMI beads.
  3. Slowly inject LC Bead LUMI solution into the delivery catheter under X-ray techniques such as fluoroscopy, CBCT and CT imaging while observing the bead distribution to avoid reflux. If there is no effect on the antegrade flow rate, choose a larger size of
    LC Bead LUMI and repeat the delivery process. Exercise conservative judgment in determining the embolization endpoint.
  4. Where necessary, saline flushes can be used to ensure full delivery of the
    LC Bead LUMI.
  5. Upon completion of the treatment, remove the catheter while maintaining gentle suction so as not to dislodge LC Bead LUMI that may still be within the catheter lumen.
  6. Discard any open unused LC Bead LUMI as well as any other ancillary equipment used in the procedure such as the ViaLok Vented Access Device, syringes, needles, catheters, etc., according to applicable local standard practice.

Packaging

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Conservation and storage:

  • Unopened LC Bead LUMI™ must be stored between 2°C to 25°C, in a dry place in its original packaging. Protect the product from direct sunlight. Use by the date indicated on the vial label.
  • Once opened, LC Bead LUMI™ must be used within 4 hours if they are kept at room temperature or within 24 hours if they are stored in a refrigerator at 2°C to 8°C.
  • Do not freeze.
 

Package label:

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