About DC BeadM1

Important Product Information

DC BeadM1TM Indications:

  • DC BeadM1TM is primarily intended as an embolic agent for the treatment of malignant hypervascularised tumour(s)
  • DC BeadM1TM is compatible with irinotecan, which can be loaded prior to embolisation and then, as a secondary action, elute a local, controlled and sustained dose to the mCRC after embolisation
  • DC BeadM1TM is compatible with doxorubicin, which can be loaded prior to embolisation and then, as a secondary action, elute a local, controlled and sustained dose to the tumour after embolisation

 

DC BeadM1TM and/or all indications may not be available in your territory. DC BeadM1TM is not currently cleared by the FDA for sale or distribution in the USA.

DC BeadM1 is a trademark of Biocompatibles UK Ltd.

 

 

Cautions:

  • Embolisation with DC BeadM1TM should only be performed by a physician with appropriate interventional occlusion training in the region intended to be embolised
  • Do not use if the vial or packaging appear damaged
  • Ensure that DC BeadM1TM is an appropriate size for the intended vasculature
  • Consider upsizing to a larger size of DC BeadM1TM in the presence of AV shunts or if angiographic evidence of embolisation does not appear quickly during delivery
  • Consideration should be given to Tc99m-MAA scanning if there is suspicion of AV shunting

Cautions:  Irinotecan-loaded DC BeadM1TM

  • On addition of non-ionic contrast/water mixture to irinotecan-loaded beads, some irinotecan will be eluted over time.  If the beads are not used immediately, up to 10mg irinotecan may be present in the contrast/water mixture.  If this occurs, a small dose of irinotecan may be available systemically at time of delivery
  • Do not use irinotecan-loaded beads with contrast agents containing salts (e.g. Calcium chloride)
  • The maximum amount of irinotecan that can be loaded is 100mg irinotecan per2ml vial of
     DC BeadM1TM
    Exceeding this amount may lead to some irinotecan remaining free in solution.  This free solution should be removed prior to use to prevent the patient receiving the excess dose as a bolus

Potential Complications:

  1. Undesirable reflux or passage of DC BeadM1TM into normal arteries adjacent to the targeted lesion or through the lesion into other arteries or arterial beds
  2. Non-target embolisation
  3. Pulmonary embolisation
  4. Ischemia at an undesirable location
  5. Capillary bed saturation and tissue damage
  6. Ischemic stroke or ischemic infarction
  7. Vessel or lesion rupture and haemorrhage
  8. Neurological deficits including cranial nerve palsies
  9. Vasospasm
  10. Death
  11. Recanalisation
  12. Foreign body reactions necessitating medical intervention
  13. Infection necessitating medical intervention
  14. Clot formation at the tip of the catheter and subsequent dislodgement

Warning:  Studies have shown that DC BeadM1TM do not form aggregates and, as a result, penetrate deeper into the vasculature as compared to similarly sized PVA particles.