EpiFix® Micronized Dehydrated Human Amnion/Chorion Membrane Allograft
EpiFix® Micronized Dehydrated Human Amnion/Chorion Membrane Allograft is intended for homologous use in the treatment of acute and chronic wounds to modulate inflammation, enhance healing and reduce scar tissue formation.
• Contains essential wound healing regulatory proteins
• 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® Micronized is intended for homologous use in the treatment of acute and chronic wounds to modulate inflammation, enhance healing and reduce scar tissue formation.
EpiFix® Micronized 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; (3) in intravenous, intra-arterial or intrathecal applications. EpiFix® Micronized should not be injected into (1) the spinal canal; (2) vital organs, including the heart; and/or (3) other areas of the circulatory system or the central nervous system.
EpiFix® Micronized 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.
Within 72 hours, the patient may experience a moderate increase in tenderness and pressure in the treated area.
This product has 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 injection, the possibility of infection exists. To minimize the risk of infection limit the exposure of the needle to pathogens.
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®.
EpiFix® Micronized should be stored in a clean, dry environment at ambient conditions.
EpiFix® Micronized has 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
Non/Minimally Exudating Wounds
Preparation, Reconstitution and Surgical Use
Prior to implantation, carefully follow the EpiFix® Micronized preparation steps below using aseptic technique:
Wound Bed Preparation
Ensure the wound is free from clinical signs of infection. Prepare wound bed as needed.
Removing EpiFix® Micronized from Packaging
The outer peel pouch is not sterile. The inner pouch containing the EpiFix® Micronized vial is sterile (unless the pouches are damaged or compromised).
Using aseptic technique, slowly peel a corner of the inner peel pouch and allow the authorized medical professional to remove the vial.
Injection Preparation Technique
Sterile 0.9% Saline Solution
One (1) x 5ml Syringe
One (1) x 18-25 Gauge Needle
Flip open the aluminum top of the vial. Wipe injection port with 70% isopropyl alcohol prep pad.
Draw up the recommended volume of 0.9% sterile saline needed for rehydration from the table below into a 5ml syringe using an 18-25 gauge needle.
The volume used is left to the discretion of the authorized medical professional.
Amount of material: 40mg; recommended volume of saline: 1ml.
Amount of material: 100mg; recommended volume of saline: 2.5ml.
Amount of material: 160mg; recommended volume of saline: 4ml.
Transfer a portion, 2ml or less, of the recommended volume of 0.9% sterile saline into the vial of EpiFix® Micronized.
Using a back and forth transfer with the plunger, mix the particulate to create a full suspension in the syringe. If time elapses between rehydration and administration and product separates, re-suspend by shaking. Use within 12 hours of reconstitution. Because the reconstituted material is viscous, use proper pre-injection techniques to reduce possible air introduction.
Dispose of any material remaining after procedure is complete in accordance with biohazardous protocols. This product is for single patient use only.
Dry the wound surface to allow for even application of the powder. Remove the foil and stopper from the vial. Apply a thin even layer of the powder onto the wound area to be treated.
Rehydration and Use as a Paste
Apply single drops of saline while mixing until desired consistency is achieved
EpiFix® Micronized is compatible with offloading/compression/negative pressure therapies and can be used in conjunction with hyperbaric oxygen therapy.
Re-application of EpiFix® Micronized
Apply additional EpiFix® Micronized when the rate of wound healing slows.
MiMedx Group, Inc. is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of health care.