Non-Degradable Elastic Design Polyvinyl Alcohol Embolic Microspheres
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
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.
CE, ISO13485
USA FDA 510K
EN ISO 13485 : 2016/AC:2016 Medical equipment quality management system for regulatory requirements
EN ISO 14971 : 2012 Medical devices - Application of risk management to medical devices
ISO 11135:2014 Medical device Sterilization of ethylene oxide Confirmation and general control
ISO 6009:2016 Disposable sterile injection needles Identify color code
ISO 7864:2016 Disposable sterile injection needles
ISO 9626:2016 Stainless steel needle tubes for the manufacture of medical devices
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