Indications for Use
Embolic Microspheres are intended to be used for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, including uterine fibroids.
Common or Usual Name: Polyvinyl Alcohol Embolic Microspheres
Classification Name: Vascular Embolization Device
Classification: Class II
Panel: Cardiovascular
Device Description
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.
Embolic Microspheres consist of a macromer derived from polyvinyl alcohol (PVA), and are hydrophilic, non-resorbable, and are available in a range of sizes.
The preservation solution is 0.9% sodium chloride solution. The water content of fully polymerized microsphere is 91% ~ 94%. Microspheres can tolerate compression of 30%.
Embolic Microspheres are supplied sterile and packaged in sealed glass vials.
Embolic Microspheres are intended to be used for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, including uterine fibroids.
By blocking the blood supply to the target area, the tumor or malformation is starved of nutrients and shrinks in size.
Embolic Microspheres can be delivered through typical microcatheters in the 1.7- 4 Fr range. At the time of use, Embolic Microspheres are mixed with a nonionic
contrast agent to form a suspension solution. Embolic Microspheres are intended for single use and are supplied sterile and non pyrogenic. The device
configurations of Embolic Microsphere are described in Table 1 and Table 2 below.
Among the various size ranges of Embolic Microspheres, the size ranges that can be used for uterine fibroid embolization are 500-700μm, 700-900μm and 900-1200μm.
| Table: Device configurations of Embolic Microspheres |
Product
Code
| Calibrated
Size (µm)
| Quantity | Indication |
Hypervascular Tumors/ Arteriovenous Malformations
| Uterine Fibroid |
| B107S103 | 100-300 | 1ml microspheres :7ml 0.9% sodium chloride | Yes | No |
| B107S305 | 300-500 | 1ml microspheres :7ml 0.9% sodium chloride | Yes | No |
| B107S507 | 500-700 | 1ml microspheres :7ml 0.9% sodium chloride | Yes | Yes |
| B107S709 | 700-900 | 1ml microspheres :7ml 0.9% sodium chloride | Yes | Yes |
| B107S912 | 900-1200 | 1ml microspheres :7ml 0.9% sodium chloride | Yes | Yes |
| B207S103 | 100-300 | 2ml microspheres :7ml 0.9% sodium chloride | Yes | No |
| B207S305 | 300-500 | 2ml microspheres :7ml 0.9% sodium chloride | Yes | No |
| B207S507 | 500-700 | 2ml microspheres :7ml 0.9% sodium chloride | Yes | Yes |
| B207S709 | 700-900 | 2ml microspheres :7ml 0.9% sodium chloride | Yes | Yes |
| B207S912 | 900-1200 | 2ml microspheres :7ml 0.9% sodium chloride | Yes | Yes |
