EpiFix® Product Overview
EpiFix® is a dehydrated Human Amnion/ Chorion Membrane (dHACM) allograft and is composed of multiple layers including a single layer of epithelial cells, a basement membrane and an avascular connective tissue matrix. EpiFix® is a minimally manipulated, dehydrated, non-viable cellular amniotic membrane allograft that preserves and delivers multiple extracellular matrix proteins, growth factors, cytokines, and other specialty proteins present in amniotic tissue to help regenerate soft tissue.
EpiFix® Amnion/Chorion Membrane Allograft for Acute and Chronic Wound Care
- Enhances Healing
- Modulates Inflammation
- Reduces Scar Tissue Formation
EpiFix® is processed using the PURION® Process, a unique approach that provides an added level of tissue safety and ease of use. EpiFix® may be stored at ambient conditions for up to 5 years and is also available in a particulate configuration. With a variety of sizes available, EpiFix® has size-appropriate grafts to minimize wastage.
AmnioFix® Product Overview
AmnioFix® is a composite amniotic tissue membrane minimally manipulated to protect the collagen matrix and its natural properties. AmnioFix® reduces scar tissue formation, modulates inflammation in the surgical site, enhances healing, and acts as a barrier.
Human amniotic membrane comprises the innermost layer of the placenta and lines the amniotic cavity. AmnioFix® is processed through the proprietary PURION® Process that combines cleaning, dehydration and sterilization, and it may be stored at ambient conditions for up to 5 years. The proprietary PURION® Process protects the delicate scaffold during processing, leaving an intact collagen matrix. The result is a durable graft with natural barrier properties to optimize surgical performance and ease of use.
MiMedx Amniotic Allografts Are Terminally Sterilized to Enhance Safety Related to Microbiological and Viral Transmission
In light of the media attention and in the wake of concerns related to the Zika virus, the Company is reiterating its long standing processing safety standards for the terminal sterilization of MiMedx amniotic allografts. The MiMedx flagship amniotic allografts have always been terminally sterilized, and the Company’s proprietary PURION® Process has continually used terminal sterilization as an essential part of the process. To address potential questions related to the Zika virus, MiMedx is reconfirming the rigorous product safety methods and practices followed by the Company in the processing of its amniotic allografts as well as restating its precise standards for screening of placenta donors.
To ensure patient safety, donor screening and testing is performed for each donor mother. Donor screening includes a review of both the donor's medical and social history to ensure that the donor has not engaged in behaviors that place her at an increased risk for the transmission of infectious disease, and to ensure that the donor has not shown signs or symptoms of illnesses.
In addition, each donor is tested for the following infectious diseases:
- Hepatitis B
- Hepatitis C
All screening and testing results are reviewed according to the company's quality management system, which is designed to meet the requirements specified in the FDA's Good Tissue Practice regulations and in the standards of the American Association of Tissue Banks. All donor screening and testing records are reviewed and accepted by QA personnel before being reviewed by our medical director, a recognized expert in infectious disease testing. Only tissue from donors with acceptable test results are released for transplant.
The company is registered with the Food and Drug Administration and licensed as a tissue bank by the states of California, Georgia, Maryland, and New York. The company is compliant with the tissue bank guidelines of the American Association of Tissue Banks as well as all applicable federal, state and local regulations
The PURION® Process
Human amniotic membrane allografts have been used for a variety of reconstructive surgical procedures since the early 1900s. The use of the amniotic membrane as an allograft has accelerated due to the development of the PURION® Process, which among other things allows the tissue to be dehydrated and sterilized.
The proprietary PURION® Process safely and gently separates placental tissues, cleans and reassembles layers, and then dehydrates the tissue to preserve the key elements associated with healing. The PURION® Process removes blood components while protecting the delicate scaffold of the amniotic membrane, leaving an intact extracellular matrix. The result is a durable graft with natural barrier properties that offers clinicians a clear advantage in soft tissue applications. PURION® processed dehydrated human amnion/chorion allografts can be stored at ambient conditions for up to five years.
The proprietary process has been specifically designed to deliver a clinically effective and minimally manipulated allograft tissue. All placental tissues are recovered under sterile conditions from patients who have been screened for underlying infectious disease. No chemicals are used in the PURION® Process that might result in chemical cross-linking or decellularization.
Amniotic Membrane Description
Human amniotic membrane is comprised of the innermost layer of the placenta and lines the amniotic cavity. The membrane is composed of multiple layers including a single layer of epithelial cells, a basement membrane and an avascular connective tissue matrix. The tissues of the placenta present a very complex interrelationship of materials that possess numerous physiologic characteristics, that can in turn change in importance with the appropriate stage of gestation. During pregnancy, the placenta permits the passage of nutrients, metabolites and metabolic gases, and provides physical and immunological protection to the developing fetus. In addition, it produces a variety of steroids and important metabolic hormones.8
Amniotic membrane is a unique material and its composition contains collagen types I, III, IV, V, and VII. Amniotic membrane is composed of structural extracellular matrix (ECM), that also contains specialized proteins fibronectin, laminins, proteoglycans and glycosaminoglycans. In addition, amniotic membrane contains essential, active, healing growth factors such as epidermal growth factor (EGF), transforming growth factor beta (TGF-b), fibroblast growth factor (FGF), and platelet derived growth factor (PDGF).8 Amniotic tissues have shown little to no HLA-A, B, C antigens and β2 microglobulin.3
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