EpiFix® Amniotic Membrane Allograft
EpiFix® Amniotic Membrane Allograft is intended for homologous use in the treatment of acute and chronic partial- and full-thickness wounds for the reduction of scar tissue formation, modulation of inflammation, and enhancement of healing.
• Composed of human amnion and chorion membranes that comprise the innermost layer of the placenta and line the amniotic cavity
• Mutiple layers, inlcuding a single layer of epithelial cells, a basement membrand and an avascular connective tissue matrix
• Contains essential wound healing growth factors
• Modulates inflammation and reduces scar tissue formation
• Platelet derived growth factor A and B promotes cell proliferation in connective tissue
• Epidermal growth factor promotes proliferation of epithelial cells
• Transforming growth factor promotes normal wound healing
• Fibroblast growth factor promotes cellular proliferation
• Stores at ambient conditions for up to five years
• Available in multiple sizes
EpiFix® is intended for homologous use in the treatment of acute and chronic wounds to reduce scar tissue formation, modulate inflammation, and enhance healing.
EpiFix® should not be used on (1) areas with active or latent infection and/or (2) a patient with a disorder that would create an unacceptable risk of post-operative complications. Not intended to be used as a bone substitute or bone replacement.
EpiFix® allografts remain 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 has not been tested in combination with other products.
DO NOT RE-STERILIZE.
As with any surgical procedure, the possibility of infection exists.
Proprietary processing and 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®.
EpiFix® allografts should be stored in a clean, dry environment at ambient conditions.
EpiFix® allografts have a five year shelf life. Check the label for the expiration date.
1. Koob TJ, Lim JJ, Massee M, Zabek N, Denozière G. Properties of dehydrated human amnion/chorion composite grafts: Implications for wound repair and soft tissue regeneration. J Biomed Mater Res B Appl Biomater. 2014 Aug;102(6):1353-62.
2. Koob TJ, Lim JJ, Zabek N, Massee M. Cytokines in single layer amnion allografts compared to multilayer amnion/chorion allografts for wound healing. J Biomed Mater Res B Appl Biomater. 2014 Aug 30.
3. Zelen CM, Serena TE, Denoziere G, Fetterolf DE. A prospective randomized comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. Int Wound J. 2013 Oct;10(5):502-7.
|Contact manufacturer for usage guidelines||●|
|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|
|Shelf life greater than 2 years|
|Shelf life limited||●|
|Variety of sizes||●|
|Educational Material Available||●|
|Free Samples/Trials Available||●|
|Published Clinical Article Available||●|
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Preparation, Reconstitution and Surgical Use:
Prior to implantation, carefully follow the EpiFix® allograft preparation steps below using aseptic technique:
Wound Bed Preparation
Ensure the wound is free from clinical sign of infection. Prepare wound bed as needed.
Removing EpiFix® from Packaging
The outer peel pouch is NOT sterile. The inner pouch that contains EpiFix® is sterile (unless the pouches are damaged or compromised).
Carefully open the peelable corner of the outer pouch and extract the inner pouch using aseptic technique. Ensure the inner pouch does not come in contact with any portions of non-sterile surface of the outer pouch.
Using aseptic technique, SLOWLY peel a corner of the inner peel pouch and allow the authorized medical professional to grasp EpiFix® with fingers or non-toothed, sterile forceps.
Use EpiFix® promptly after opening the inner, sterile pouch.
PLEASE TAKE GREAT CARE WHEN REMOVING EPIFIX® FROM THE INTERNAL POUCH. EPIFIX® IS THIN AND EXTREMELY LIGHTWEIGHT.
In a dry state, use sterile dry scissors to cut EpiFix® to fit within the wound margins. It is acceptable to overlap the wound margins with EpiFix® by 1mm. If needed, EpiFix® can be fenestrated to accommodate wounds that produce copious amounts of exudate.
EpiFix® can be applied wet or dry.
EpiFix® can be hydrated while on the wound site with sterile saline solution. Simply apply several drops of sterile solution to EpiFix®. During and following hydration, the embossment on EpiFix® will begin to fade.
EpiFix® Orientation & Application
EpiFix® should be placed on the wound site, using the orientation of the embossment lettering as a guide. Proper orientation of EpiFix® can be noted when the embossment nomenclature reads correctly from left to right.
Absorbable, non-absorbable suture material and/or tissue adhesives can be used to fixate EpiFix® to the wound site.
EpiFix® is compatible with offloading/compression/negative pressure therapies.
EpiFix® can be used in conjunction with hyperbaric oxygen therapy.
Re-application of EpiFix®
It is recommended that EpiFix® grafts are 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 EpiFix® on a biweekly basis if desired.
EpiFix® should be covered with a non-adherent contact layer.
EpiFix® 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.
EpiFix® requires a moist wound environment. Use appropriate moisture management dressings for the wound type and treatment ideology.
MiMedx Group, Inc. develops, processes, manufactures and markets patented biomaterial products and tissues including EpiFix® Amniotic Membrane Allograft for acute and chronic wounds.