LC Bead™ Brief Summary
Indications, Safety and Warnings
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 catheter placement 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 from which they emerge
- Presence of patent extra-to-intracranial anastomoses or shunts
- Presence of collateral vessel pathways potentially endangering normal territories during embolisation
- Presence of end arteries leading directly to cranial nerves
- Presence of arteries supplying the lesion not large enough to accept LC Bead microspheres
- Vascular resistance peripheral to the feeding arteries precluding passage 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 the blood does not pass through the arterial/capillary/venous transition but 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 of large diameter arteriovenous shunts (ie. where the blood does not pass through the arterial/capillary/venous transition but directly from artery to vein
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