BioXclude™ is a processed, dehydrated and sterilized graft composed of allograft amnion and chorion tissue (300 µm thick) that undergoes Purion® processing technology.
BioXclude™ is terminally sterilized by electron beam.
All placental tissue used in BioXclude™ is donated under full informed consent from mothers undergoing elective cesarean section delivery. The tissue is procured and processed according to regulations established by the United States Food & Drug Administration and the standards of the American Association of Tissue Banks.
A safe and biocompatible material, amnion tissue was used as early as the 1900’s, for skin transplantation to treat burn victims and those with ulcerated skin conditions. Amnion and amnion chorion tissue-based products have been used in ophthalmic surgery for the last decade and more recently in spine and orthopedic surgery and the treatment of chronic wounds. During this time there have been no reported incidents of any type of adverse event associated with their use.
The Science of Placental Allografts
Placental allografts are composed of immunoprivileged tissues that possess anti-bacterial properties, reduce wound site inflammation, and provide a protein enriched matrix to facilitate cell migration¹. BioXclude™ is sourced from the amniotic sac, the part of the placenta that encloses and protects the developing fetus through term.
Amniotic tissue consists of an inner amnion layer and an outer chorion layer. Amnion contains collagen Types III, IV, and V². Chorion, the outer layer of the amniotic sac, contains collagen Types I, III, IV, V, and VI.³
Each allograft undergoes Purion®, a proprietary tissue processing technology designed to cleanse and maintain the delicate structure of tissues.
1. Chen E H, Tofe A J. A literature review of the safety and biocompatibility of amnion tissue. J Impl Adv Clin Dent 2010; 2(3): 67-75.
Features & Benefits
· Composed of immunoprivileged tissue
· Reduces inflammation at the wound site
· Contains laminin and laminin-54
· Minimal trimming needed; can fold onto itself and be placed over exposed roots
· Tightly adapts over placed bone graft and proximal bony walls
· Does not need to be secured into place with sutures or tacks
BioXclude is available in membranes of:
· 8x8 mm
· 12x12 mm
· 10x20 mm
· 15x20 mm
· 15x25 mm
· 20x30 mm