LC Bead™ Brief Summary

Indications, Safety and Warnings

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INDICATIONS

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

CONTRAINDICATIONS

  • Patients intolerant to occlusion procedures
  • Vascular anatomy or blood flow that precludes catheterplacement or emboli injection
  • Presence or likely onset of vasospasm
  • Presence or likely on set of hemorrhage
  • Presence of severe atheromatous disease
  • Presence of feeding arteries smaller than distal branches fromwhich they emerge
  • Presence of patent extra-to-intracranial anastomoses or shunts
  • Presence of collateral vessel pathways potentially endangeringnormal territories during embolisation
  • Presence of end arteries leading directly to cranial nerves
  • Presence of arteries supplying the lesion not large enough toaccept LC Bead microspheres
  • Vascular resistance peripheral to the feeding arteries precludingpassage of LC Bead microspheres into the lesion
  • Do not use LC Bead microspheres in the following applications:
    • Embolisation of large diameter arteriovenous shunts (ie. where theblood does not pass through the arterial/capillary/venous transitionbut directly from artery to vein
    • The pulmonary arterial vasculature
    • Any vasculature where the use of LC Bead Embolic Agent could pass directly into the internal
Embolisation with LC Bead microspheres should only be performed by physicians who have received appropriate interventional occlusion training in the region intended to be embolised.

POTENTIAL COMPLICATIONS

  • Undesirable reflux or passage of LC Bead microspheres 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.
  • Pulmonary embolisation
  • Ischemia at an undesirable location
  • Capillary bed saturation and tissue damage
  • Ischaemic stroke or Ischaemic infarction
  • Vessel or lesion rupture and hemorrhage
  • Neurological deficits including cranial nerve palsies
  • Vasospasm
  • Death
  • Recanalisation
  • Foreign body reactions necessitating medical intervention
  • Infection necessitating medical intervention
  • Clot formation at the tip of the catheter and subsequent dislodgement

 

PI-719210-AA

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