allogen is a multipurpose, frozen allograft derived from amniotic...
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To place an order, please contact: [email protected] West Oak Pkwy., Suite 200, Marietta, Georgia 30062 | 855-MY-VIVEX | www.vivex.com
AlloGen™ is a multipurpose, frozen allograft derived from amniotic fluid.
Just as amniotic fluid protects and nourishes the fetus during development, AlloGen provides the same protection to injured or traumatized tissue. Amniotic fluid contains various proteins that support cell proliferation, movement and differentiation. Amniotic fluid also includes collagen substrates, growth factors, amino acids, polyamines, lipids, carbohydrates, cytokines, extracellular matrix molecules like hyaluronic acid and fibronectin, cells and other chemical compounds that are needed for tissue protection and repair.
Amniotic fluid is rich in the components that are believed to contribute to a wound healing response characterized by minimal inflammatory activity and regenerative rather than scar-mediated healing. These components work to kick-start the body’s own rejuvenation and healing process. As an all natural liquid matrix, AlloGen Amniotic Fluid Therapy (AFT)™ can be easily applied directly at the site of injury, inflammation and pain.
Fig. 1 — Growth Factors Present in AlloGen™
TIMP-2
HGF
TIMP-3
TIMP-1
IGF-2 IL-
6IG
F-1
GRO-alpha
TGF-B2
TGF-B1IL-
1RA
TIMP-4
MCP-1 EGF
TGF-alpha
TNF-alpha0
1000
2000
ng G
F/m
L of
Sup
erna
tant
3000
4000
5000
6000
7000
Clinical Applications:• Orthopedics – augment tendon, fasciae, ligament and capsule repair• Neurosurgery – chronic neuritis and pain• Spinal Surgery – facet inflammation• General Surgery – augment tissue repair
Recommended Preparation Instructions: • For single patient one time use, AlloGen is packaged frozen with a locked cap and stored at -80°C ± 15°C with a 2 year shelf life. It is intended for use as an additive for surgical applications associated with soft tissue procedures.
• Remove product from cold storage and open outer packaging, thaw vial in hand
• Using aseptic technique, draw allograft out of vial with a ~ 30 gauge or larger needle.
• The HCT/P is ready to use (may or may not be used with a dilutent).
FDA Regulatory: • Qualifies as a 361 tissue • Minimally manipulated • FDA considers the use of amnion to be for homologous use
Ordering information:
ITEM PRODUCTNUMBER DESCRIPTION
ALL-0025 AlloGen (small, 0.25ml)
ALL-0050 AlloGen (medium, 0.50ml)
ALL-0100 AlloGen (large, 1.00ml)
ALL-0200 AlloGen (x large, 2.00ml)
1. Grazul-Bilska, AT et al. Wound Healing: The Role of Growth Factors, Drugs Today (Barc) 2003. 39(10): 787-800.2. Barrientos, S et al. Growth Factors and Cytokines in Wound Healing, Wound Repair Regen 2008. 16(5):585-601.3. Werner, S et al. Regulation of Wound Healing by Growth Factors and Cytokines, American Physiological Society 2003. 83(3):835-870.
MKG-30016Rev. 01
To place an order, please contact: [email protected] West Oak Pkwy., Suite 200, Marietta, Georgia 30062 | 855-MY-VIVEX | www.vivex.com