A Comparative Study of Spherical Embolisation Particles

Our Results in an Animal Model

Presented during
A Comparative Study of Spherical Embolisation Particles: Our Results in an Animal Model.

Year
2006

Abstract Number
1053

Authors
Esther de Luis, Clinica Universitaria de Navarra; Pamplona, Navarra, Spain; M. Dolores Lozano; Jose A. Garcia Jalon; Antonio Martinez-Cuesta; Octavio Cosin; Jose I. Bilbao

Purpose

To study four spherical embolisation particles' behaviour, in an animal model, and their adaptability to the arterial wall. To show histological aspects of particle embolisation and differences between four spherical embolisation particles.

Materials

Embosphere™, Contour™, Bead Block™ (150-350μ) and HepaSphere™ (50μ dry state) were used in a comparative study. Both renal arteries were embolised in each animal (19 swine). Pigs were sacrificed 48 hours (9 animals) and four weeks after the embolisation (9 animals). Specimens were studied with specific stains.

Results

Mean size of the particles were 120μ for Contour™, 110 μ for Embosphere™, 96 μ for Bead Block™ and 200 μ for HepaSphere™. The measurements were performed in histological slices after embolisation. Embosphere™ maintained their shape and occluded medium size arteries. Bead Block™ reached small calliper arteries, maintained their spherical shape and induced ischemic necrosis of the vessel wall. Contour™ reached small arteries and had an amorphous shape, not spherical in histological specimens. HepaSphere™ maintained their spherical shape and adapted perfectly to the arterial wall.

Conclusions

Although all four materials are spherical and are similar in size (in vitro) we have found differences in terms of final size and shape of the particles. The adaptation of the spheres to the arterial wall is not the same and this particular aspect may have interest in terms of choosing the embolisation material for each clinical situation.

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 Blockā„¢ 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