In vivo evaluation of a new embolic spherical particle (HepaSphere) in a kidney animal model.

HepaSphere is a new spherical embolic material developed in a dry state that absorbs fluids and adapts to the vessel wall, leaving no space between the particle and the arterial wall. The aim of this study was to elucidate the final in vivo size, deformation, final location, and main properties of the particles when reconstituted with two different contrast media (Iodixanol and Ioxaglate) in an animal model. Two sizes of "dry-state" particles (50-100 and 150-200 microm) were reconstituted using both ionic and nonionic contrast media. The mixture was used to partly embolize both kidneys in an animal model (14 pigs). The animals were sacrificed 4 weeks after the procedure and the samples processed. The final size of the particles was 230.2 +/- 62.5 microm for the 50- to 100-microm dry-state particles and 314.4 +/- 71 microm for the 150- to 200-microm dry-state particles. When the contrast medium (ionic versus nonionic) used for the reconstitution was studied to compare (Student's t-test) the final size of the particles, no differences were found (p > 0.05). The mean in vivo deformation for HepaSphere was 17.1% +/- 12.3%. No differences (p > 0.05) were found in the deformation of the particle regarding the dry-state size or the contrast medium (Mann-Whitney test). We conclude that HepaSphere is stable, occludes perfectly, and morphologically adapts to the vessel lumen of the arteries embolized. There is no recanalization of the arteries 4 weeks after embolization. Its final in vivo size is predictable and the particle has the same properties in terms of size and deformation with the two different contrast media (Iodixanol and Ioxaglate).