Shelter™ Placental-Derived Allograft is comprised of the amniotic and chorionic membranes of the placenta. This product is designed as an innovative solution to serve as a barrier or wound cover for acute and chronic wounds. Leveraging the structural and biochemical properties of placental tissue, Shelter™ offers a comprehensive biologic approach for a variety of acute or chronic wound applications.
Product Overview
Minimally manipulated and dehydrated
Derived from human amniotic and chorionic membrane
Retains the structural and functional characteristics of the starting placental membranes
Packaged in different sizes and verified to be terminally sterilized to a 10⁻⁶ Sterility Assurance Level (SAL)
Product PROPERTIES
Placental Tissue
Placental tissue, once considered biologic waste following delivery, is a pristine newly formed extracellular matrix (ECM) that protects and supports fetal development. This tissue represents an untainted extracellular matrix—essentially a neomatrix.
Placental tissue broadly includes:
Amnion (fetus-facing layer): Thinner yet more compact extracellular matrix Chorion (maternal-facing layer): Slightly thicker but less compact matrix
Both layers are constituted primarily of collagen fibers (Types I, III, IV, and V) along with other ECM proteins including laminin, fibronectin, proteoglycans, and hyaluronic acid.
Safety & Tissue Sourcing
Donated tissues are collected from fully consented mothers undergoing full-term C-sections
1: Each donor is screened according to standards required by the U.S. Food and Drug Administration (FDA) and the American Association of Tissue Banks (AATB)
2: Products undergo a validated terminal sterilization process
3: Tissue is obtained through FDA-regulated and accredited recovery organizations
Intended Use
Shelter™ Placental-Derived Allograft (361 HCT/Ps) is intended as a natural biologic wound covering or skin substitute for cutaneous wounds. Use by qualified healthcare professionals is for application in physician office, outpatient, or inpatient settings.
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