*Not currently available for sale outside of the U.S.*
Product Description
Origen™ DBM with Bioactive Glass is a bone void filler comprised of a gelatin carrier, Bioactive Glass (45s5) and human demineralized bone matrix (DBM) intended for transplantation. Origen™ has been formulated to reconstitute into a paste upon addition of a sterile fluid (e.g. sterile saline, water for injection). Origen™ is provided in a sterile, single-use syringe. Since Origen™ contains biological materials, some variations in product appearance and handling should be expected. Origen™ is pyrogen free.Indication
Origen™ DBM with Bioactive Glass is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient’s skeletal system.Physician Support Materials
Pre-Clinical References
Origen™ is the first off-the-shelf DBM-Bioactive Glass product available for use in an orthopedic clinical setting. As an adjuvant to demineralized bone matrix, Bioactive Glass facilitates operative site graft containment through rapid bone bonding and the subsequent activation of cellular osteogenesis. The combined properties of DBM and Bioactive Glass create a favorable environment for bone fusion. Origen™ is a novel composite allograft expressly designed to optimize surgical handling performance, graft stability, and osteoproductivity.
Hench LL, et al. Bioactive Glasses for in situ Tissue Regeneration. Journal of Biomaterial Science and Polymer Education Volume 15, Number 4, 2004.
Day RM. Bioactive Glass Stimulates the Secretion of Angiogenic Growth Factors and Angiogenesis in Vitro. Tissue Engineering Volume 11 Number 5/6; 2005.
Xynos, I.D., et al. Gene-Expression Profiling of Human Osteoblasts Following Treatment With the Ionic Products of Bioglass 45S5 dissolution. J. Biomed. Mater. Res. 2001;55(2):151-157.
Allan, I., et al. Antibacterial Activity of Particulate Bioglass Against Supra- and Subgingival Bacteria. Biomaterials. 2001;22(12):1683-1687.
Part Reference Numbers
| Part Reference No. | Description |
|---|---|
| 22-2002 | Origen DBM 2 cc |
| 22-2005 | Origen DBM 5 cc |
| 22-2010 | Origen DBM 10 cc |
Contraindications
Origen™ Bioactive Glass with DBM is contraindicated where the device is intended as structural support in load-bearing bone and in articulating surfaces. Infection at the surgical site and/or distant foci of infections that may spread to the surgical site is a contraindication.
Do not use Origen™ Bioactive Glass with DBM if package integrity has been compromised.
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