Vitoss BA2X
Bioactive Bone Graft Substitute
A synthetic bone graft substitute that has increased levels of bioactive glass compared to Vitoss BA, and has a unique porosity, structure, and chemistry to help drive 3-D regeneration of bone.
Vitoss BA2X Bioactive Bone Graft Substitute
Vitoss BA2X contains increased levels of bioactive glass compared to Vitoss BA. In-vitro testing showed that it induced two times the deposition of calcium phosphate onto the surface of an implant while retaining the same handling properties.2
Bioactive glass contains three ionic constituents - silicon, sodium, and calcium. Upon implantation, these ionic constituents are released into the surround environment and react with bodily fluids.3-7 This reaction produced the deposition of a thin layer of physiologic calcium phosphate at its surface, favorable for osteoblast attachment.7 This is commonly referred to as a bioactive effect, and may lead to the bonding of new bone to the scaffold.5,8-13 In vitro testing showed cells exposed to Stryker’s proprietary formulation of bioactive glass demonstrated increased cell proliferation, increased collagen elaboration, and increased mineralization compared to cells cultured without exposure to bioactive glass.14
Highly porous beta-tricalcium phosphate (up to 90%)15 containing bioactive glass and resorbs during the natural remodeling process of bone16
Available in Foam Pack forms which can soak and hold various hydration fluids including saline, blood and bone marrow aspirate (BMA)17
The addition of bioactive glass helps create a surface favorable for osteoblast attachment.5,8-13
Note: In-vitro bioactivity testing has not been evaluated in human clinical trials.
References:
- Stryker Test Report: 1050-0003R.
- Stryker Test Report: 1000-2024R
- Hench, L.L. The Story of Bioglass. Journal of Materials Science: Materials in Medicine, 2006 Nov; 17(11): 967-78.
- Oonishi, H., et al., Particulate Bioglass Compared with Hydroxyapatite as a Bone Graft Substitute. Clinical Orthopaedics and Related Research, 1997 Jan; 334: 316-25.
- Vrouwenvelder, W.C.A., Histological and Biochemical Evaluation of Osteoblasts Cultured on Bioactive Glass, Hydroxylapatite, Titanium Alloy, and Stainless Steel. Journal of Biomedical Materials Research, 1993 Apr; 27(4): 465-75.
- Xynos, I.D., Edgar, A.J., Buttery, L.D.K., Hench, L.L., and Polak, J.M., Ionic Products of Bioactive Glass Dissolution Increase Proliferation of Human Osteoblasts and Induce Insulin-like Growth Factor II mRNA Expression and Protein Synthesis. Biochemical and Biophysical Research Communications. 2000 Sep 24;276(2):461-5.
- Hench, L.L., Polak, J.M., Xynos, I.D., Buttery, L.D.K., Bioactive Materials to Control Cell Cycle. Materials Research Innovations, 2000; 3(6): 313-323.
- Hench, L.L., Splinter, R.J., and Allen, W.C., Bonding Mechanisms at the Interface of Ceramic Prosthetic Materials. Journal of Biomedical Materials Research, 1971; 2(1): 117-141.
- Hench, L.L., Paschall, H.A., Direct Chemical Bond of Bioactive Glass-Ceramic Materials to Bone and Muscle. Journal of Biomedical Materials Research, 1973; 4: 25-42.
- Gross, U., The Interface of Various Glasses and Glass Ceramics with a Bony Implantation Bed. Journal of Biomedical Materials Research, 1985; 19: 251-271.
- Sanders, D.M., Hench, L.L., Mechanisms of Glass Corrosion. Journal of American Ceramic Society.1973; 56(7): 373-377.
- Hench, L.L., Characterization of Glass Corrosion and Durability. Journal of Non-Crystalline Solids, 1975; 19: 27-39.
- Ogino, M., Hench, L.L., Formation of Calcium Phosphate Films on Silicate Glasses. Journal of Non-Crystalline Solids, 1980; 38 and 39: 673-678.
- Reza, A. 61st Annual Meeting of the Orthopedic Research Society, 2015. P1163.
- Stryker Test Report: 1070-0008R.
- Anker et al, Ultraporous Beta-Tricalcium Phosphate is Well Incorporated in Small Cavitary Defects. Clinical Orthopaedics and Related Research, 2005 May; 434: 251-7.
- Vitoss BA2X IFU, 5333-0018, Rev 01
Based on BIVIT-WB-9_16136