<i>In vivo</i> evaluation of callispheres microspheres in the porcine renal artery embolization model.

Abstract

This study aimed to evaluate the operational performance, embolization effect and safety of CalliSpheres microspheres (CSM) in a porcine renal model. 24 healthy normal pigs were randomized into CSM group and Embosphere microspheres (ESM) group equally, and embolized with CSM or ESM in the lower pole of right kidneys, respectively. On D2, D7 and D28 after the operation, angiography and biochemistry examination were performed, and then the pigs were subjected to renal macroscopic and histopathological examination after euthanasia (4 pigs/group per each time point). The embolization was performed successfully in all pigs without obvious adverse events or deaths, and there was no difference in operation assessments (including number of embolized arteries, volume of injected microspheres and vessel recanalization rate) between CSM group and ESM group. After the operation, all pigs in CSM group and ESM group presented with renal necrosis, stasis and capsule exudation on D2 and D7, and capsule thickening, fibrosis and renal atrophy on D28, and there was no difference in these macroscopic or microscopic manifestations between two groups. For biochemistry indexes (including blood routine, coagulation function, liver function and renal function), most of them were similar between two groups at each time point. CSM embolizes porcine renal artery effectively and safely without obvious adverse events or deaths, which might be a good option for embolization therapy in clinical practices.