Vascular Embolization Device Polyvinyl Alcohol Embolic Microspheres

Vascular Embolization Device Polyvinyl Alcohol Embolic Microspheres

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Vascular Embolization Device Polyvinyl Alcohol Embolic Microspheres

  • Product Details
PVA Embolic Microspheres

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.

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.

Note on Uterine Fibroid Embolization (UFE):
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
Item Code

Calibrated Size

(µm)

Quantity  

(Microspheres : Saline)

Indication

Hypervascular Tumors  / AVMs

Uterine  

Fibroids

B107S103100-3001ml microspheres : 7ml 0.9% NaClYesNo
B107S305300-5001ml microspheres : 7ml 0.9% NaClYesNo
B107S507500-7001ml microspheres : 7ml 0.9% NaClYesYes
B107S709700-9001ml microspheres : 7ml 0.9% NaClYesYes
B107S912900-12001ml microspheres : 7ml 0.9% NaClYesYes
B207S103100-3002ml microspheres : 7ml 0.9% NaClYesNo
B207S305300-5002ml microspheres : 7ml 0.9% NaClYesNo
B207S507500-7002ml microspheres : 7ml 0.9% NaClYesYes
B207S709700-9002ml microspheres : 7ml 0.9% NaClYesYes
B207S912900-12002ml microspheres : 7ml 0.9% NaClYesYes