What is 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
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

 

Product Code	Calibrated Size (µm)	Quantity	Indication
			Hypervascular Tumors/ Arteriovenous Malformations	Uterine Fibroid
U107S103	100-300	1ml microspheres : 7ml 0.9% sodium chloride	Yes	No
U107S305	300-500	1ml microspheres : 7ml 0.9% sodium chloride	Yes	No
U107S507	500-700	1ml microspheres : 7ml 0.9% sodium chloride	Yes	Yes
U107S709	700-900	1ml microspheres : 7ml 0.9% sodium chloride	Yes	Yes
U107S912	900-1200	1ml microspheres : 7ml 0.9% sodium chloride	Yes	Yes
U207S103	100-300	2ml microspheres : 7ml 0.9% sodium chloride	Yes	No
U207S305	300-500	2ml microspheres : 7ml 0.9% sodium chloride	Yes	No
U207S507	500-700	2ml microspheres : 7ml 0.9% sodium chloride	Yes	Yes
U207S709	700-900	2ml microspheres : 7ml 0.9% sodium chloride	Yes	Yes
U207S912	900-1200	2ml microspheres : 7ml 0.9% sodium chloride	Yes	Yes