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Product Detail

Vascular Embolization Device Polyvinyl Alcohol Embolic Microspheres

Product details

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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)
QuantityIndication

Hypervascular   

Tumors/

Arteriovenous

  Malformations

Uterine   

Fibroid

B107S103100-300

1ml   microspheres :7ml 0.9% sodium chloride

YesNo
B107S305300-500

1ml   microspheres :7ml 0.9% sodium chloride

YesNo
B107S507500-700

1ml   microspheres :7ml 0.9% sodium chloride

YesYes
B107S709700-900

1ml   microspheres :7ml 0.9% sodium chloride

YesYes
B107S912900-1200

1ml   microspheres :7ml 0.9% sodium chloride

YesYes
B207S103100-300

2ml   microspheres :7ml 0.9% sodium chloride

YesNo
B207S305300-500

2ml   microspheres :7ml 0.9% sodium chloride

YesNo
B207S507500-700

2ml   microspheres :7ml 0.9% sodium chloride

YesYes
B207S709700-900

2ml   microspheres :7ml 0.9% sodium chloride

YesYes
B207S912900-1200

2ml   microspheres :7ml 0.9% sodium chloride

YesYes



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