BioXclude™

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BioXclude™ is a processed, dehydrated and sterilized graft composed of allograft amnion and chorion tissue (300 µm thick).

Description

Description

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.

Overview

Overview

Safety information
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

Purion® Process
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. 
2. Hodde J. Naturally occurring scaffolds for soft tissue repair and regeneration. Tiss Eng 2002; 8(2):295-308. 
3. Niknejad H, Peirovi H, Jorjani M, et al. Properties of the amniotic membrane for potential use in tissue engineering. Euro Cells & Mat 2008; 15: 88-89.
4. Xenoudi P, Lucas M. Comparison of porcine and amnion chorion resorbable collagen membranes using immunohistochemistry. IADR 2011, San Diego, CA March 16-19; Abstract #146797.
5. Holtzclaw, D. BioXclude placental allograft tissue membrane used in combination with bone allograft for site preservation: A case series. J Impl Adv Clin Dent 2011; 3(3): 35-50.
6. Rosen, P. BioXclude allograft placental tissue membrane in combined regenerative therapy in the treatment of a periodontal intrabony defect: A case report. November 2010. Retrieved from http://www.snoasismedical.com. 
7. Wallace, S. Use of allograft amnion chorion membrane in ridge augmentation with simultaneous implant placement: A case report. April 2011. Retrieved from http://www.snoasismedical.com.

Features

Features

Features & Benefits
· Composed of immunoprivileged tissue
· Reduces inflammation at the wound site
· Contains laminin and laminin-54
· Resorbable
· 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

Availability

Availability

BioXclude is available in membranes of:
· 8x8 mm
· 12x12 mm
· 10x20 mm
· 15x20 mm
· 15x25 mm
· 20x30 mm

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