General Information
Human placental tissue offers a new and exciting material for use in dental surgery. This section of
the website is to help patients learn more about the tissue used in BioXclude®, how it’s obtained, and where it can be used. Snoasis Medical’s patient section is for informational purposes only and is not intended to replace the advice or instruction of your dental treatment provider.
Snoasis
Medical's product, BioXclude, is composed of processed human placental
tissue, specifically, amnion and chorion tissue. These two layers are
commonly referred to as the amniotic sac, which encloses and protects
the unborn baby through pregnancy. All tissue is donated under full
informed consent from mother’s undergoing elective cesarean section delivery and would otherwise be discarded. BioXclude can be used as a wound covering in a variety of dental applications which include covering bone graft material in the treatment of bony defects around teeth, in procedures performed in conjunction with the placement or repair of dental implants, or other bone reconstruction procedures. It can also be used to treat some forms of gingival recession and in tissue augmentation procedures.
Safety Information
All placental tissue is procured under full informed consent from mothers who donate their placenta during elective caesarian section delivery. The tissue is procured, processed and distributed in compliance with federal regulations and tissue standards of the American Association of Tissue Banks. A thorough medical and social history of the donor is also obtained, including detailed family history. All recovered tissue meets stringent specifications during donor screening and laboratory testing to reduce the risk of transmitting infectious disease. Each donor is screened for:
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Separating the amnion from the chorion tissue. |
Cleansed amnion tissue is prepared for dehydration. |
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All test results are reviewed prior to the release of the tissue. Only tissue from donors with acceptable test results are released as specified by standards established by Snoasis Medical, its manufacturer, MiMedx Group, and all state and federal regulatory bodies.
Following procurement, the tissue is prepared for commercialization using a proprietary process (Purion®) that cleanses and preserves the inherent extracellular matrix of the amnion chorion allograft. After which it is dehydrated, packaged and terminally sterilized (SAL 10-6).