AmnioFix® is a biologic Amniotic Membrane processed through Surgical Biologic's proprietary Purion® process, which combines cleaning, dehydration and sterilization to produce a safe, technically sterilized tissue allowing for storage at room temperature.
AmnioFix® is processed from Human tissue according to the American Association of Tissue Banks (AATB) regulations, and is considered tissue under Section 361 of the Public Health Service Act. This means that AmnioFix®is regulated differently than the other two MiMedx platform technologies, CollaFix® and HydroFix®, which are regulated as medical devices and therefore need FDA clearances prior to marketing in the United States. Since it is regulated as a tissue, AmnioFix® does not need such clearance or approval in the United States.
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Soft Tissue Applications
Our AmnioFix® Technology utilizes Purion®, a proprietary tissue processing technology which produces an implant which is safe, effective, and minimally manipulated.
Each processing step, including sterilization, has been validated to ensure tissue integrity and safety. Our processing technique specifically focuses on maintaining the delicate multi-layered structure and collagen matrix of the tissue. The approach to processing utilized by Surgical Biologics differentiates itself from other process methodologies. The Purion® process does not subject materials to ultra low temperature conditions during processing or storage. This technique helps maintain graft structure, provides optimal performance and allows for the implant to be stored at room temperature. Additionally, each implant incorporates specialized visual embossments which assist the surgeon with proper graft placement and orientation.
Properties of the amniotic membrane for potential use in tissue engineering. Niknejad, et. al; European Cells and materials Vol. 15: 88-99; 2008.
Implantation of amniotic membrane to reduce postlaminectomy epidural adhesions. Tao and Fan; Eur Spine; DOI 10.1007/s00586-009-1013-x; 2009.
Amniotic membrane transplantation for ocular surface disease; Memarzadeh MD, et al; Opthalmology Vol. 3 No. 1; 15 Jan 2004.
A novel dehydrated amnion allograft for use in the treatment of gingival recession: an observational case series; Gurinsky, DDS, MS; The Journal of Implant & Advanced Clinical Dentistry; Vol. 1, No. 1 (65-73); March 2009.