LC Bead LUMI™ is intended to be used for the embolization of hypervascular tumors and arteriovenous malformations.
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
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
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 sequel, 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
Corporate and Regional Press Releases
Corporate press releases are selected from information communicated on www.btgplc.com and are selected because the information relates to BTG products available in various countries. The information is not being shared to advocate use of a product outside of its locally approved indication for use.