Bead Block USA

Bead Block

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 embolic agent offers:

  • Proven performance for the embolization of hypervascular tumors and arteriovenous malformations (AVMs)
  • Blue-tinted beads, in prefilled, color-coded syringes for added convenience and safety
  • Precisely calibrated sizing for effective and accurate embolization
  • Compressible spherical embolic with 100% elastic shape recovery for easier delivery
  • Confidence of product and clinical support from Biocompatibles – leaders in embolization technology

Embolization of hypervascular renal tumors in combination therapy

Bead Block embolic agent offers the benefits associated with targeted occlusion of renal vessels and is ideally suited for super-selective arterial embolization.  Recent studies* have demonstrated that super selective embolization of renal tumors prior to resection or ablation may offer the following benefits:

  • Preservation of renal function
  • Reduced RFA heat sink effect
  • Reduced probability of bleeding
  • Eliminate the need to clamp renal vessels

In the United States of America, Bead Block™ is indicated for the treatment of hypervascularized tumors and arteriovenous malformations.

* Recent Studies:

  1. Hoffman, R.T.; Jakobs, T.F; Kubishc, C.H.; Trumm, C.; Siebels, M.; Helmberger, T.K.; Reiser, M.F. Renal cell carcinoma in patients with a solitary kidney after nephrectomy treated with radiofrequency ablation:  mid term results.  Eur. J. Radiol. 2010, 73, 652-656.
  2. Woodrum D.A.; Artwell T.D.; Farrell M.A.; Andrews J. C.; Charboneau J.W.; Callstrom M.R. Role of intraarterial embolization before cryoablation of large renal tumors:  a pilot study.  J Vasc Interv Radiol. 2010 Jun;21(6):930-6.
  3. Simone G.; Papalia R.; Guaglianone S.; Carpanese L.; Gallucci M. Zero ischemia laparoscopic partial nepherectomy after superselective transarterial tumor embolization for tumors with moderate nephrometry score:  long-term results of a single-center experience.  J Endourol. 2011; 25(9): 1443-6.
  4. Simone G.; Papalia R.; Guaglianone S.; Forestiere E.; Gallucci M.; Preoperative superselective transarterial embolization in laparoscopic partial nephrectomy:  technique, oncologic, and functional outcomes.  J Endourol. 2009 Sep; 23(9):1473-8.

Regulatory notice and product safety data

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