LC Bead® - FAQs

What is LC Bead® tinted with?
How is LC Bead® packaged?
What size range is LC Bead® available?
How many beads are there per vial of LC Bead®?
How long will LC Bead® stay in the arteries?
Can we load LC Bead® with drug?
What are the indications for LC Bead®?
Is LC Bead® approved by the FDA?
Can I use Ethiodol® with LC Bead®?
Can I join a clinical trial on LC Bead®?
Do you have any information about the clinical use of LC Bead®?


What is LC Bead® tinted with?

  • LC Bead® is tinted with a dye called Reactive Blue 4 (CI 61205). This dye has many names such as: ProcionBlue MR, Reactive Brilliant Blue, Reactive Blue MR
  • Reactive Blue 4 (CI 61205) has been used in many applications and is routinely used for the tinting of contact lenses.


How is LC Bead® packaged?

  • LC Bead® is presented in a 10ml glass vial
  • Each vial contains approximately 2ml of LC Bead® in non-pyrogenic, sterile, physiological buffered saline. The total volume of saline and LC Bead® is approximately 8ml. The vial is stopper sealed by an aluminium cap equipped with a color-coded lid
  • Each vial is intended for single use only
  • The vial should not be re-sterilized and any unused material should be discarded


What size range is LC Bead® available?

  • LC BeadM1® is available in one size: 70-150μm
  • LC Bead® is available in 3 sizes from 100μm to 700μm


How many beads are there per vial of LC Bead®?

  • When using LC Bead®, the volume of embolic required to reach the desired end point is the critical factor
  • The number of individual beads is not usually considered when deciding the volume to deliver to the patient
  LC BeadM1® 70-150µm LC Bead® 100-300µm LC Bead® 300-500µm LC Bead® 500-700µm
Approximate number of beads in 2ml vial* 1,300,000 200,000 38,000 10,000
* Theoretical calculation based on the average diameters of a normal distribution of beads in a vial. Biocompatibles data on file.
 

How long will LC Bead® stay in the arteries?

  • LC Bead® is classified as a permanent embolic
  • No visible change to the product has been observed in histological analyses reported in: 
    • 3 month intrahepatic implants in vivo*
    • 6 month subcutaneous implants in vivo**
    • 12 month intracerebral implants in vivo*** 

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 * Lewis AL, et al, JVIR (2006): 17; 1335-1343
** NAmSA, report on file at Biocompatibles
*** Vinchon-Petit S, et al, Int J Pharmaceut (2010): 402: 184-9
 
 

 Can we load LC Bead® with drug?

  • LC Bead® is only cleared by the FDA for the embolization of hypervascular tumors and arteriovenous malformations (AVMs)
 

What are the indications for LC Bead®?

  • LC Bead® is cleared by the FDA for the embolization of hypervascular tumors and arteriovenous malformations (AVMs)
 

Is LC Bead® approved by the FDA?

  • LC Bead® is cleared by the FDA for the embolization of hypervascular tumors and arteriovenous malformations (AVMs)
 

Can I use Ethiodol® with LC Bead®?

  • When using LC Bead® you do not need to add Ethiodol®
 

Can I join a clinical trial on LC Bead®?

  • On-going clinical trials are available on: Home - ClinicalTrials.gov
  • Please contact principal investigators if you are interested in one of the LC Bead® clinical trials

Do you have any information about the clinical use of LC Bead®?