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Sunsphere is intended to be used for the embolization of hypervascular tumors, including uterine fibroids, and arteriovenous malformations (AVMs).

This proposed device is composed of polyvinyl alcohol embolic microspheres stored in a preservation solution of 0.9% sodium chloride. The proposed devices are compressible hydrogel microspheres with a regular shape, smooth surface, and calibrated size, which are formed as a result of chemical modification on polyvinyl alcohol (PVA) materials. Sunspheres are chemically cross-linked to form the microsphere. Microspheres are round in appearance with uniform size distribution and are available in blue dyed and undyed (colorless) microspheres. The proposed device available in blue dyed and undyed (colorless) version, which are available in 1 mL and 2 mL volumes, and 6 different calibrated particle sizes from 90 to 1000 um. Different particle sizes are distinguished by the color of the matching vial cap. The proposed device is supplied sterile and packaged in sealed glass vials.