About LC Bead®

LC Bead® is only available in

Important Product Information

LC Bead® and LC BeadM1Indications:

LC Bead® and LC BeadM1™ and/or all indications may not be available in your territory.

LC Bead® and LC BeadM1™ are 510K cleared by the FDA for the embolization of hypervascularized tumors and arteriovenous malformations (AVMs) in the USA only.

Cautions:

  • Do not use if the vial or packaging appear damaged
  • Sterile and single use product.  Do not reuse
  • Select the size and quantity of LC Bead® or
    LC BeadM1
  • Ensure that LC BeadM1™ is an appropriate size for the intended vasculature
  • Monitor patients carefully for signs of non-target embolization such as hypoxia or CNS changes
  • Consider upsizing LC BeadM1™ if angiographic evidence of embolization does not appear quickly during delivery
  • Embolization with LC Bead® and LC BeadM1™ microspheres should only be performed by physicians who have received appropriate interventional occlusion training in the region intended to be embolized

Potential Complications:

  1. Undesirable reflux or passage of LC Bead® or
    LC BeadM1™ into normal arteries adjacent to the targeted lesion or through the lesion into other arteries or arterial beds, such as the internal carotid artery, pulmonary, or coronary circulations
  2. Non-target embolization
  3. Pulmonary embolization
  4. Ischemia at an undesirable location
  5. Capillary bed saturation and tissue damage
  6. Ischemic stroke or Ischemic infarction
  7. Vessel or lesion rupture and haemorrhage
  8. Neurological deficits including cranial nerve palsies
  9. Vasospasm
  10. Death
  11. Recanalization
  12. Foreign body reactions necessitating medical intervention
  13. Infection necessitating medical intervention
  14. Clot formation at the tip of the catheter an subsequent dislodgement

Caution:

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