LC Bead® - Instructions for use


INDICATIONS:

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


DESCRIPTION:

LC Bead® comprise a range of hydrogel microspheres that are biocompatible, hydrophilic, nonresorbable and precisely calibrated. LC Bead® microspheres are produced from polyvinyl alcohol and are available in the following size ranges:

Size Label Color

  • 100 – 300 µm Yellow
  • 300 – 500 µm Blue
  • 500 – 700 µm Red
  • 700 – 900 µm Green
  • 900 – 1200 µm Purple

 
PRESENTATION:

  • Glass vial of 10ml
  • Stopper sealed by an aluminum cap equipped with a colored cap
  • Each vial contains approximately 1ml or 2ml of LC Bead® in a
  • non-pyrogenic sterile physiological buffered saline.
  • Each vial is intended for single patient use only. Do not resterilize. Discard any unused material

 
CLINICAL APPLICATIONS:

The scientific literature provides extensive documentation of embolization procedures using a wide variety of artificial agents in both neurological and peripheral vascular systems, including the head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal system, limbs and lungs. A representative bibliography is provided following these instructions for use.

CONTRAINDICATIONS:

  1. Patients intolerant to occlusion procedures.
  2. Vascular anatomy or blood flow that precludes catheter placement or emboli injection.
  3. Presence or likely onset of vasospasm.
  4. Presence or likely on set of hemorrhage.
  5. Presence of severe atheromatous disease.
  6. Presence of feeding arteries smaller than distal branches from which they emerge.
  7. Presence of patent extra-to-intracranial anastomoses or shunts.
  8. Presence of collateral vessel pathways potentially endangering normal territories during embolization.
  9. Presence of end arteries leading directly to cranial nerves.
  10. Presence of arteries supplying the lesion not large enough to accept LC Bead® microspheres.
  11. Vascular resistance peripheral to the feeding arteries precluding passage of LC Bead® microspheres into the lesion.
  12. Do not use LC Bead® microspheres in the following applications: Embolization of large diameter arteriovenous shunts (ie. where the blood does not pass through the arterial/capillary/venous transition but directly from artery to vein.
    1. The pulmonary arterial vasculature.
    2. Any vasculature where the use of LC Bead® Embolic Agent could pass directly into the internal carotid artery or the above listed vessels.


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® microspheres appropriate for the pathology to be treated.
  • Embolization with LC Bead® microspheres should only be performed by physicians who have received appropriate interventional occlusion training in the region intended to be embolized.


WARNING: Studies have shown that LC Bead® microspheres do not form aggregates and, as a result, penetrate deeper into the vasculature as compared to similarly sized PVA particles. Care must be taken to choose a larger sized LC Bead® Embolic Agent when embolizing arteriovenous malformations with large shunts to avoid passage of the microspheres into the pulmonary or coronary circulation.
 
The color of the LC Bead® microspheres could be visible through
the skin if injected into arteries feeding superficial tissues.