EPIFIX® Dehydrated Human Amnion/Chorion Membrane (DHACM) Allograft
EPIFIX® is a dehydrated human placental allograft that includes the amnion layer and chorion layer. EPIFIX® provides a protective barrier on wounds and thereby supports development of granulation tissue and the healing process.
MIMEDX Group, Inc.
MIMEDX is a pioneer and leader in placental biologics focused on delivering innovative solutions to patients and the health care professionals who treat them. With more than a decade of helping clinicians manage chronic and other hard-to-heal wounds, MIMEDX has been dedicated to providing a leading portfolio of products for applications in the wound care, burn, and surgical recovery sectors of health care.Benefits
• Provides a protective barrier on wounds and thereby supports development of granulation tissue and the healing process.
• PURION® process preserves Extracellular Matrix (ECM) components, including 300+ regulatory proteins
• Terminally sterilized for an additional level of safety
• Shelf stable, five year shelf life
• Compatible with negative pressure wound therapy (NPWT) and hyperbaric oxygen therapy (HBO)
Indications
EPIFIX® is intended for homologous use in the treatment of acute and chronic wounds to provide a protective barrier thereby supporting the healing process.
Contraindications
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.
Warnings and Precautions
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.
Adverse Effects/Reactions
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®.
Storage Requirements
It is the responsibility of the distributor and/or end-user clinician to store EPIFIX® allografts in a clean, dry environment between 2–30°C prior to further distribution or transplant. EPIFIX® allografts have a 5-year shelf life. Check the label for the expiration date.
How Supplied/Sizing
14mm disc, 16mm disc, 18mm disc, 24mm disc, 2cm x 2cm sheet, 2cm x 3cm sheet, 2.5cm x 2.5cm sheet, 2cm × 4cm sheet, 3cm × 3cm sheet, 3cm × 4cm sheet, 3.5cm x 3.5cm sheet, 4cm × 4cm sheet, 3cm × 5cm sheet, 4cm × 6cm sheet, 5cm x 5.3cm sheet, 5 cm x 6cm sheet, 7cm x 7cm sheet, 2cm x 3cm mesh sheet, 3.5cm x 3.5 cm mesh sheet, 3cm x 5 cm mesh sheet, 4cm x 4.5cm mesh sheet, 5cm x 5.5 cm mesh sheet
Patient condition
HCPCS Code
Product features
Assigned HCPCS code
Minimally manipulated
Cryopreserved
Dehydrated
Desiccated
Flowable
Micronized
Sheet form
Requires refrigeration
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
Other features
Educational Material Available
Free Samples/Trials Available
Published Clinical Article Available
Recommended Use
Acute Wounds
Chronic Wounds
Debridements
Dehisced Wounds
Diabetic Foot
Granulating/Epithelializing Wounds
Moderate/Highly Exudating Wounds
Mohs Repair
Pressure Ulcers
Superficial Wounds
Venous Ulcers
Mode of Use/Application
EPIFIX® Preparation In a dry state, use sterile dry scissors to cut EPIFIX® to to fit the wound margins.
Depth of the wound should be taken into consideration, allowing contact of EPIFIX with the wound bed and walls to the edges and overlapping, as appropriate. It is acceptable to overlap the wound margins with EPIFIX by 5-10mm to facilitate fixation to the tissue, or amount deemed medically necessary by the provider.
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.
Additional Recommended Dressings
Primary Dressing 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. Secondary Dressing EPIFIX® requires a moist wound environment. Use appropriate moisture management dressings for the wound type and treatment ideology.
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