A Simply Remarkable Tissue!

Amnion is a placental tissue that surrounds and protects the fetus during development in utero.  The properties of amnion that benefit the fetus also make it an effective material for protecting a wide variety of wounds, while at the same time creating an environment conducive to the regeneration of healthy tissue.  Repurposing this versatile tissue to improve outcomes in wound management is supported by studies in published literature which describes its successful and safe clinical use.

Amnion membranes consist primarily of fibrillar and membranous collagens, elastin, and a mix of growth factors and cytokines that provide the properties unique to placental tissues.

The Benefits of SteriShield II™ Amnion Membranes

The scientific and peer reviewed literature describe a number of benefits from the clinical use of amnion tissues, including:

• Safe, natural covering that improves normal wound healing outcomes
• Reduced inflammation
• Reduced fibrosis and scarring at the surgical site and Decreases pain
• Provides a substrate for stem cells

SteriShield II™ Dual Layer Amnion Membranes have the following advantages:

• Improved handling characteristics due to thickness
• Surface layer dimpling for ease of graft placement and handling
• Eliminates need to apply with one side towards wound (epithelial layer faces out on both sides)
• Eliminates risk of error in applying products – sidedness issue
• When placed in water or saline, the graft will unfold and can be repositioned Stores dry at room temperature
• Suitable for immediate use off the shelf
• Hydrates rapidly in wound environment
• Readily adheres to the wound surface
• Terminally sterilized with gamma radiation to SAL 10^-6 in accordance with ISO 11137
• Not chemically cross-linked
• Three year shelf life
• Can be placed with either side in contact with the wound surface
• If not initially placed properly during surgery the membrane can either be manipulated in place or removed; when placed in water or saline, the membrane will unfold and can be repositioned

Tissue Safety

• Collection of the donor tissue is performed in an aseptic manner by appropriately licensed tissue establishments
• Placentas are all from planned C-sections which helps to minimize the potential for contamination during recovery
• Placental donors go through a rigorous pre-screening qualification
• Placental donors are tested to confirm that they are free from disease
• Processed in accordance with the safety guidelines provided by the U.S. Food and Drug Administration (FDA) - Human Cellular and Tissue-base Products (HCT/P) (21 CFR Part 1271)
• Processed in accordance with the standards from the American Association of Tissue Banks (AATB