EpiFix® (MiMedx Group) is a bioactive tissue matrix allograft composed of dehydrated human amniotic/chorionic membrane that is used as an allograft material (or tissue graft) to treat nonhealing wounds.
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What is EpiFix made of?
EpiFix (MiMedx) amniotic membrane allograft is made of dehydrated human amnion/chorion membrane tissue (dHACM). The tissue is derived from amniotic membranes donated with informed consent in the US. EpiFix is terminally sterilised to reduce virus transmission.
How long does it take EpiFix to work?
Key outcomes 40% wound closure at 4 weeks was used as a surrogate end point for complete healing and was the primary outcome of the study. At 4 weeks, 62% of ulcers in the EpiFix group and 32% of ulcers in the control group had reduced in size by more than 40% (p=0.005).
How often is EpiFix applied?
In a randomized clinical trial using EpiFix® on diabetic foot ulcers, 50% of patients healed completely within 2 weeks1. It may take multiple graft applications to close the wound based on wound size, wound depth and desired rate of closure. Apply additional grafts weekly or biweekly, according to physician discretion.
Is EpiFix an implant?
( OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected biomaterial-based products and bioimplants processed from human amniotic membrane, announced today the nation-wide launch of the Company’s latest product, EpiFix™, a biologic implant specifically processed to offer a wide variety of …
Is EpiFix a skin substitute?
EpiFix is a multi-layer biologic dehydrated human amniotic membrane allograft comprised of an epithelial layer and two fibrous connective tissue layers specifically processed to be used for the repair or replacement of lost or damaged dermal tissue.
How do you use Epifix graft?
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® should be placed on the wound site, using the orientation of the embossment lettering as a guide.
Is Epifix covered by Medicare?
The coverage by CGS now brings the total Medicare Administrative Contractors (MACs) covering EpiFix® to six of the eight and 86% of Medicare beneficiaries will now be eligible for coverage for EpiFix® products.
How much is Epifix?
The cost of the EpiFix product was therefore much lower at $1669 per patient compared with $9216 per patient for Apligraf.
What is EpiFix or Epicord?
EpiCord, a thick membrane derived from human umbilical cord, provides a protective environment for healing. EpiFix, bioactive tissue composed of dehydrated human amnion/chorion membrane, serves as a skin substitute.
What is meant by allograft?
Medical definitions for allograft allograft. [ ăl′ə-grăft′ ] n. A graft of tissue obtained from a donor genetically different from, though of the same species as the recipient.
What is the purpose of Endoform?
Endoform is an extracellular matrix (ECM) that supports all the phases of wound healing. Endoform is a collagen dressing that promotes healing in acute and chronic wounds and is widely accessible to wound care clinicians.
What is EPI burn?
EpiBurn is a bioactive tissue matrix composed of human amnion/chorion membrane. EpiBurn has multiple layers including a layer of epithelial cells, a basement membrane, and an avascular connective tissue matrix.
Who makes AmnioFix?
MiMedx Group, Inc. AmnioFix® Injectable Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the FDA for the Treatment of Osteoarthritis of the Knee.
What is AmnioFill?
AmnioFill® is a placental-based tissue matrix in a particulate. configuration to replace or supplement damaged or. inadequate integumental tissue in acute and chronic. closures in comorbid patients.
What is the difference between EpiFix and AmnioFix?
Whereas AmnioFix is a composite minimally manipulated amniotic tissue membrane, EpiFix is dehydrated human amnion/chorion membrane (dHACM) allograft and is composed of multiple layers preserved through gentle cleansing and dehydration process.
What sizes does EpiFix come in?
- GS-5140: EpiFix® Amnion/Chorion Membrane Allograft, 1.5 sq cm.
- GS-5180: EpiFix® Amnion/Chorion Membrane Allograft, 2.5 sq cm.
- GS-5220: EpiFix® Amnion/Chorion Membrane Allograft, 4 sq cm.
- GS-5024: EpiFix® Amnion/Chorion Membrane Allograft, 4.5 sq cm.
- GS-5230: EpiFix® Amnion/Chorion Membrane Allograft, 6 sq cm.
Is TheraSkin FDA approved?
TheraSkin is among the first FDA-approved skin healing systems that uses real skin from screened donors instead of animal by-products or synthetic materials.
Does Medicare cover skin grafts?
Medicare usually doesn’t cover cosmetic surgery unless you need it because of accidental injury or to improve the function of a malformed body part. Medicare covers breast prostheses for breast reconstruction if you had a mastectomy because of breast cancer.
Is EpiFix experimental?
Aetna considers EpiFix experimental and investigational for all other indications (e.g., Stevens-Johnson syndrome / toxic epidermal necrolysis syndrome).
How does scleroderma affect wound healing?
Scleroderma is an autoimmune disorder that causes fibrosis and scarring of the connective tissue, with loss of skin elasticity and loss of joint range of motion. Dermal wounds may occur spontaneously or from trauma.
How do I order Epifix?
Prefer to get start over the phone give us a call 1 (833) 844 – 9621. If you don’t have a prescription or need to renew your prescription, we can connect you with a US licensed medical professional for an online doctor visit for E.D., hair loss, birth control, cold sores, acid reflux, and high cholesterol.
What is dermagraft?
Dermagraft is a sterile, cryopreserved, human fibroblast–derived dermal substitute generated by the culture of neonatal dermal fibroblasts onto a bioresorbable polyglactin mesh scaffold (Fig. 1).
How do you use Epicord?
Using aseptic technique, slowly peel a corner of the inner peel pouch and grasp the allograft with fingers or non-toothed, sterile forceps. Use the EPICORD® allograft promptly after opening the inner, sterile pouch. Please take great care when removing the product from the internal pouch.
What is considered a skin substitute?
Skin substitutes are a heterogeneous group of biologic, synthetic, or biosynthetic materials that can provide temporary or permanent coverage of open skin wounds. Skin substitutes ideally possess the composition and function of skin or have the potential for autologous regenerative healing when applied to a wound [2].