|
 For patients lacking proper bone structure, IMTEC Corporation now offers cortical demineralized bone. Cortical demineralized bone is produced for use in the reconstruction of maxillary or mandibular defects, or to assist in regeneration of bone tissue to maximize the potential for implant success.
To incorporate cortical demineralized bone material into bone regeneration procedures, mix the bone tissue with patient’s blood to form a loose paste, then insert the paste into the required areas according to the IMTEC bone/tissue regeneration protocol.
IMTEC cortical demineralized bone is derived from qualified donors, free from risk factors and disease according to U.S. FDA guidelines. A multi-stage processing system is used to ensure the product is pure and free from contaminates. No foreign substances are added to the material, resulting in the final product being classified (by the U.S. FDA) as a tissue.
Processing Treatment:
The Processing treatment begins by separating usable tissue and crushing it to the proper size, .125mm to .850mm sized particles. The particles are then sent through a two stage washing process consisting of a hydrochloric acid bath wash and then an aseptic bath. (This procedure is the patented Allowash™ System.) The hydrolic acid bath reduces the levels of calcium in the tissue to less than one percent, which is recommended for a high degree of success. Cortical demineralized bone is then freeze-dried and packaged in the same container and exposed to gamma radiation to assure the highest safety standards are achieved.
The preparation of bone grafts involves soaking and rinsing in the following solutions to clean and aid in inhibiting
bacterial growth:
- Antibiotics
- Hydrogen Peroxide
- Alcohol
- Sterile water
The patented Allowash™ Treatment is extremely effective against viruses and bacteria. The Allowash™ technique
consists of three different chemicals used to effectively remove cellular elements from musculoskeletal tissue while
maintaining structural integrity.
The following tests are performed
by Community Tissue Services on bone grafts:
|
Serological
Tests
|
Required
by IMTEC to be performed by Community Tissue Services
|
Required
by AATB
|
Required
by FDA
|
|
HIV1/2Ab
Human Immunodeficiency Types 1 and 2 Antibody
|
·
|
·
|
·
|
|
HIV PCR
Polymerase Chain Reaction (test for HIV Virus DNA)
|
·
|
|
|
|
HTLV1/2Ab
Human T-Lymphotropic Virus Types 1 and 2 Antibody
|
·
|
·
|
|
|
HbsAg
Hepatitis B Surface Antigen
|
·
|
·
|
·
|
|
HbcAb
Hepatitis B Core Antibody
|
·
|
|
|
|
HCVAb
Hepatitis C Antibody
|
·
|
·
|
·
|
|
RPR/STS
or Equivalent: Syphiis
|
·
|
·
|
|
|
Irradiated
after Sterilization *
|
·
|
|
|
* The Gamma Irradiation process performed by Tissue Community Services of Dayton, Ohio is an added step to decrease
bacteria and viral risks to the patient.
- Community Tissue Services practices both Aseptic Processing and Terminal Gamma Irradiation.
- Controlled Residual Calcium level less than 1% to provide optimum results.
- The shelf life of a bottle of demineralized bone is 5 years.
|
