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.
For more information, please refer to package insert.
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
- Niknejad H; Peirovi H; Jorjani M; Ahmadiani A; Ghanavi J; Seifalian AM "Properties of the amniotic membrane for potential use in tissue engineering." Eur Cell Mater. (15). 01-JAN-2008. pp 88 - 99.
- Rahman I; Said DG; Maharajan VS; Dua HS "Amniotic membrane in ophthalmology: indications and limitations." Eye. (23)10. 2009. pp 1954–1961.
- Baradaran-Rafii A; Aghayan H; Arjmand B; and Javadi M. "Amniotic Membrane Transplantation." Iran J Ophthalmic Res. (2)1. 2007. pp 58-75.
- John, T. "Human amniotic membrane transplantation: Past, present, and future.." Ophthal Clin N Am. (16). 2003. pp 43-65.
- Adly OA; Moghazy AM; Abbas AH; Ellabban AM; Ali OS; Mohamed BA "Assessment of amniotic and polyurethane membrane dressings in the treatment of burns." Burns - 01-AUG-2010; 36(5): 703-10.
- Huiren Tao & Hongbin Fan "Implantation of amniotic membrane to reduce postlaminectomy epidural adhesions." Eur Spine J - 01-AUG-2009; 18(8): 1202-12. (). 2009.
- Arora R; Mehta D; Jain V "Amniotic membrane transplantation in acute chemical burns." Eye (Lond). (19)3. 01-MAR-2005. pp 273-8.
- Kay H; Nelson D; Wang Y. “The Placenta: From Development to Disease.” Wiley-Blackwell. 2011.