Microspheres And Pva Particles
Polyvinyl Alcohol Embolic Microspheres
Indications for Use
Polyvinyl Alcohol 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 size ranges: 75-150μm, 100-300μm, 300-500μm, 500-700μm, 700-900μm, 900-1200μm
- Formed from chemical modification on polyvinyl alcohol (PVA) materials
- Hydrophilic and non-resorbable
- Preservation solution: 0.9% sodium chloride solution
- Available in dyed (blue) and clear (undyed) variants
- Supplied in sterile sealed glass vials containing 1 mL, 2 mL, or 3 mL of microspheres suspended in 7 mL, 7 mL, or 6 mL of 0.9% sodium chloride solution
- Compressibility: 50% by diameter
- Compatible delivery catheters: 1.7-4.0 Fr
- Mixed with non-ionic contrast media prior to injection
- Delivery method: Via catheter under fluoroscopic visualization
- Sterile and single use
- Sterilization: Moist heat (121°C, 20 minutes) achieving SAL of 10^-6
- Shelf life: 3 years
- Polymerization method: Suspension polymerization
- Storage media: 0.9% sodium chloride solution
- Packaging: Sealed in borosilicate glass vials
Description
The subject device polyvinyl alcohol embolic microspheres 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. The embolic microspheres consist of a macromer derived from polyvinyl alcohol (PVA) and are hydrophilic, non-resorbable. The preservation solution is 0.9% sodium chloride solution.