Microspheres And Pva Particles
Sunsphere
Indications for Use
Sunsphere is intended to be used for the embolization of hypervascular tumors, including uterine fibroids, and arteriovenous malformations (AVMs).
Key Specifications
- Composed of polyvinyl alcohol (PVA) embolic microspheres
- Stored in 0.9% sodium chloride preservation solution
- Compressible hydrogel microspheres with regular shape and smooth surface
- Calibrated size from 90 to 1000 μm
- Specific size ranges: 70-120 μm, 150-250 μm, 350-450 μm, 550-650 μm, 700-900 μm, 900-1100 μm
- Chemically cross-linked PVA materials
- Round appearance with uniform size distribution
- Available in blue dyed and undyed (colorless) versions
- Volumes: 1 mL and 2 mL embolic microspheres in 7 mL 0.9% sodium chloride
- Supplied sterile in sealed borosilicate glass vials
- Non-resorbable
- Compressibility: 30% by diameter
- Delivered via micro-catheter under DSA
- Compatible with 1.7-4.0 Fr delivery catheters
- Radiopacity achieved by mixing with non-ionic contrast agent prior to injection
- Sterile and single use
- Shelf life: 2 years
- Sterilization: Moist heat steam (121°C, 30 minutes) to achieve SAL of 10^-6
- Bacterial endotoxin levels below 0.5 EU/mL
Description
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.