LC BeadM1 ® - FAQs

How is LC BeadM1® packaged?
What size is LC BeadM1® available?
How many beads are there per vial of LC BeadM1®?
How long will LC BeadM1® stay in the arteries?
What is LC BeadM1® tinted with?
Can we load LC BeadM1® with drug?
Can I join a clinical trial on LC BeadM1®?
Do you have any information about the clinical use of LC BeadM1®?
What are the indications for LC BeadM1®?
Is LC BeadM1® approved by the FDA?
Can I use Ethiodol® with LC BeadM1®?



How is LC BeadM1® packaged?

  • LC BeadM1® is presented in a 10ml glass vial
  • Each vial contains approximately 2ml of LC BeadM1® in non-pyrogenic, sterile, physiological buffered saline. The total volume of saline and LC BeadM1® is approximately 8ml. The vial is stopper sealed by an aluminum cap with a black 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 is LC BeadM1® available?

  • LC BeadM1® is available in a single size 70 - 150μm
 

 How many beads are there per vial of LC BeadM1®?

  • When using LC BeadM1®, 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
  • Approximate number of beads in a 2ml LC BeadM1® vial: 1,300,000*
 

* Theoretical calculation based on the average diameters of a normal distribution of beads in a vial. Biocompatibles        data on file
 

 How long will LC BeadM1® stay in the arteries?

  • LC BeadM1®, like LC Bead® is classified as a permanent embolic
  • No visible change to the LC Bead® 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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 Above data based on LC Bead® and not LC BeadM1®
 
* 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

 
What is LC BeadM1® tinted with?

  • LC BeadM1® is tinted with a dye called Reactive Blue 4 (CI 61205)Reactive Blue 4 (CI 61205) has been used in many applications and is routinely used for the tinting of contact lenses. This dye has many names such as:
    • Procion Blue MR
    • Reactive Brilliant Blue
    • Reactive Blue MR

Can we load LC BeadM1® with drug?

  • LC BeadM1® is only cleared by the FDA for the embolization of hypervascular tumors and arteriovenous malformations (AVMs)


Can I join a clinical trial on LC BeadM1®?

  • There are currently no active clinical trials with LC BeadM1®
  • The clinical trials for other Biocompatibles products are available on: Home - ClinicalTrials.gov
  • Please directly contact the principal investigators of the clinical trial you are interested in


Do you have any information about the clinical use of LC BeadM1®?


What are the indications for LC BeadM1®?

  • LC BeadM1® is cleared by the FDA for the embolization of hypervascular tumors and arteriovenous malformations (AVMs) 


Is LC BeadM1® approved by the FDA?

  • LC BeadM1® is cleared by the FDA for the embolization of hypervascular tumors and arteriovenous malformations (AVMs)


Can I use Ethiodol® with LC BeadM1®?

  • When using LC BeadM1® you do not need to add Ethiodol