AmnioFill® Human Placental Tissue Allograft
AmnioFill® is a placental connective tissue matrix to replace or supplement damaged or inadequate integumental tissue and modulate inflammation, enhance healing and reduce scar tissue formation.
• Human collagen matrix
• Contains growth factors that modulate inflammation, reduce scarring and enhance healing
• Versatile tissue form provides a scaffold for ingrowth in acute and chronic wounds
• Stores at ambient condition for up to five years
• Available in multiple sizes
AmnioFill® is intended for homologous use as a placental connective tissue matrix to replace or supplement damaged or inadequate integumental tissue for acute and chronic wounds and modulate inflammation, enhance healing and reduce scar tissue formation.
AmnioFill® should not be used (1) on areas with active or latent infection; (2) on a patient with a disorder that would create an unacceptable risk of post-operative complications. This product is not intended for injection applications.
AmnioFill® remains suitable for transplantation in an unopened, undamaged package, under proper storage conditions.
Please inspect the integrity of the package upon receipt. If package and contents appear defective or damaged in any way, immediately contact the distributor. This allograft is intended for single-patient use only. Discard all unused material.
The procedure should be performed by an authorized medical professional.
Strict donor screening and laboratory testing, along with dedicated processing and sterilization methods, are employed to reduce the risk of any disease transmission.
However, as with all biological implants, an absolute guarantee of tissue safety is not possible. This allograft has the potential to transmit infectious disease to the recipient.
The reaction of the body to any biological implant is not completely understood.
Caution should be used when treating patients with a known sensitivity to aminoglycoside antibiotics.
Discard all damaged, mishandled or potentially contaminated tissue.
This product had not been tested in combination with other products.
Do not re-sterilize.
Do not mix with anything other than sterile 0.9% saline solution.
As with any procedure, the possibility of infection exists.
Proprietary processing and validated sterilization methods are employed to eliminate potential deleterious components of the allograft. However, as with all biological implants, the possibility of rejection exists.
Any adverse reactions, including the suspected transmission of disease attributable to this allograft, should be reported immediately to MiMedx®.
AmnioFill® allografts should be stored in a clean, dry environment at ambient conditions.
AmnioFill® allografts have a five year shelf life. Check the label for the expiration date.
|Assigned HCPCS code|
|Shelf life greater than 2 years||●|
|Shelf life limited|
|Indicated for acute wounds||●|
|Indicated for chronic wounds||●|
|Indicated for diabetic ulcers|
|Indicated for pressure ulcers|
|Indicated for surgical wounds|
|Indicated for third-degree burns|
|Indicated for venous ulcers|
|Contact manufacturer for usage guidelines||●|
|Educational Material Available||●|
|Free Samples/Trials Available||●|
|Published Clinical Article Available|
Moderate/Highly Exudating Wounds
Preparation, Reconstitution and Use:
Prior to implantation, carefully follow AmnioFill® allograft preparation steps below using aseptic technique:
Removing AmnioFill® from packaging:
The outer peel pouch is not sterile. The inner vial which contains the AmnioFill® allograft is sterile (unless the pouches are damaged or compromised). Using aseptic technique, slowly peel a corner of the peel pouch and remove the vial.
AmnioFill® Preparation and Application:
AmnioFill® can be applied by dispersing the product from the vial uniformly onto the treatment area. Take care to carefully apply the product evenly over the site. AmnioFill® can be hydrated while on the wound site with sterile saline solution. Simply apply several drops of sterile solution to the product.
AmnioFill® should be covered with a non-adherent contact layer when used to treat topical wounds. AmnioFill® should not be disturbed, if possible, for several days or before the next application, if needed. If an infection occurs at the graft site, treat infection per institution's protocol.
AmnioFill® requires a moist wound environment. Use appropriate moisture management dressings for the wound type and treatment ideology.
AmnioFill® allografts are compatible with offloading/compression/negative pressure therapies. AmnioFill® can be used in conjunction with hyperbaric oxygen therapy.
It is recommended that AmnioFill® is applied weekly until wound epithelialization is achieved. However, clinician discretion should be used based on patient and wound condition/progress. It is clinically acceptable to apply AmnioFill® on a biweekly basis if desired.
MiMedx Group, Inc. is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of health care.