Standalone
CalliSpheres Embolic Microspheres
Indications for Use
Callispheres Embolic Microspheres and 8Spheres Embolic Microspheres are intended to be used for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, including uterine fibroids.
Key Specifications
- Compressible hydrogel microspheres with regular shape and smooth surface
- Calibrated sizes: 100-300 μm, 300-500 μm, 500-700 μm, 700-900 μm, 900-1200 μm
- Materials: Derived from polyvinyl alcohol (PVA) macromer, hydrophilic, non-resorbable
- Water content: 91% ~ 94%
- Compressibility: Tolerates 30% compression by diameter
- CalliSpheres: Dyed blue for visualization
- 8Spheres: Undyed with natural color
- Preservation solution: 0.9% sodium chloride solution
- Quantities: 1 mL microspheres in 7 mL saline (total 8 mL) or 2 mL microspheres in 7 mL saline (total 9 mL)
- Delivery: Through 1.7-4 Fr microcatheters, mixed with nonionic contrast agent
- Sizes for uterine fibroid embolization: 500-700 μm, 700-900 μm, 900-1200 μm
- Supplied sterile, non-pyrogenic, single use in sealed glass vials
- Shelf life: 2 years
- Sterilization: Moist heat (121°C, 30 min) to SAL 10^-6
Description
CalliSpheres and 8Spheres Embolic Microspheres are compressible hydrogel microspheres with a regular shape, smooth surface, and calibrated size, formed as a result of chemical modification on polyvinyl alcohol (PVA) materials. They consist of a PVA-derived macromer, are hydrophilic and non-resorbable, available in sizes from 100-1200 μm, with 91-94% water content and 30% compressibility. CalliSpheres are blue-dyed for visibility; 8Spheres are undyed. Supplied sterile in glass vials with 0.9% sodium chloride solution, for single-use embolization via microcatheters.