Instructions for use

Indications:

Bead Block® is an embolic agent intended for the purpose of embolizing the blood vessels of a variety of hypervascularized tumors and arteriovenous malformations. 

Bead Block® is a preformed, deformable embolic agent consisting of a biocompatible, hydrogel acrylamido polyvinyl alcohol macromer.

Bead Block® is a compressible embolic agent used in embolization therapy. This is a minimally invasive (non-surgical) procedure performed by an interventional radiologist. By blocking the blood supply to the target area, the tumor or malformation is starved of nutrients and shrinks in size.
 
 
Bead Block® - Instructions for Use


Potential Complications:

  1. Undesirable reflux or passage of Bead Block® into normal arteries adjacent to the targeted lesion/tumor or through the lesion/tumor into other arteries or arterial beds 
  2. Non-target embolization
    1. Pulmonary embolism
    2. Pancreatitis
  3. Ischaemia at undesirable locations
  4. Post embolization syndrome
  5. Capillary bed saturation and tissue damage
  6. Ischaemic stroke or ischaemic infarction
  7. Vessel or lesion/tumor rupture and haemorrhage
  8. Neurological deficits including cranial nerve palsies
  9. Liver abscess
  10. Vasospasm
  11. Death
  12. Recanalisation
  13. Foreign body reactions necessitating medical intervention
  14. Infection necessitating medical intervention
  15. Clot formation at the tip of the catheter and subsequent dislodgement

Caution:

Federal (USA) law restricts the sale of this device by or on order of a physician.

Refer to the Bead Block® IFU for all complications.
* Size restrictions apply to this indication.