Vascular Embolization Device Polyvinyl Alcohol Embolic Microspheres

Indications for Use (Describe)

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

Indication

Product

Code

Calibrated

Size (µm)

Quantity

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