Bead Block

Bead BlockBead Block is an embolic device intended for the purpose of embolising the blood vessels of a variety of hypervascularised tumours (e.g. uterine fibroids) and arteriovenous malformations. Bead Block is a preformed, deformable microsphere consisting of a biocompatible, acrylamido polyvinyl alcohol macromer.

Bead Block compressible microspheres are used in embolisation therapy. This is a minimally invasive (non-surgical) procedure performed by an interventional radiologist. By blocking the blood supply to the target area, the tumour or malformation is starved of nutrients and shrinks in size.

Bead Block microspheres are produced from a biocompatible polyvinyl alcohol hydrogel. The microspheres are tinted blue for easy visualisation and are supplied pre-filled colour coded syringes for added procedural safety and efficiency.

Bead Block received CE Mark approval in Europe in June 2003 and Bead Block is most commonly used for the treatment of uterine fibroids and other benign (non-malignant) tumours.

In the United States of America, Bead Block is indicated for the treatment of hypervascularised tumours and arteriovenous malformations.

Regulatory notices and product safety data

Worldwide (excluding USA)

Bead Block™ is CE marked and indicated for the treatment of a variety of hypervascular tumours (including Uterine Fibroids) and arteriovenous malformations (AVMs). Bead Block™ may not be indicated for the treatment of Uterine Fibroids in your country, please check with your local distributor. For full prescribing information please refer to Bead Block instructions for use.

USA

Bead Block is intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs)

Bead Block Cautions:

  • Do not use if the syringe or packaging appear damaged
  • Sterile and single use product.  Do not reuse
  • Select the size and quantity of Bead Block microspheres appropriate for the pathology to be treated
  • Embolization with Bead Block microspheres should only be performed by physicians who have received appropriate interventional occlusion training in the region intended to be embolized

For instructions for use, please refer to www.biocompatibles.com/beadblock-ifu

Bead Block Potential Complications:

  • Undesirable reflux or passage of Bead Block into normal arteries adjacent to the targeted lesion or through the lesion into other arteries or arterial beds, such as the internal carotid artery, pulmonary, or coronary circulations
  • Pulmonary embolization
  • Ischemia at an undesirable location
  • Capillary bed saturation and tissue damage
  • Ischemic stroke or ischemic infarction
  • Vessel or lesion rupture and haemorrhage
  • Neurological deficits including cranial nerve palsies
  • Vasospasm
  • Death
  • Recanalization
  • Foreign body reactions necessitating medical intervention
  • Infection necessitating medical intervention
  • Clot formation at the tip of the catheter and subsequent dislodgement