- •1.1. Background of the bion™Project
- •1.2. Design Philosophy
- •2.1.1.1.2. Electrochemical Characteristics
- •2.1.1.1.3. Biocompatibility
- •2.1.1.1.4. The Use of Tantalum in Medical Applications
- •2.1.1.1.5. Surface Characteristics and Biocompatibility of Tantalum
- •6.2.Iridium (Ir)
- •6.2.1.1.Physical/Chemical properties
- •6.2.1.2.Use of Iridium in Medical Applications
- •6.3.Borosilicate glass
- •2.2. Biocompatibility as judged by in vitro and in vivo testing
- •2.2.1. Published Pre-Clinical Research
- •2.2.2. Unpublished Pre-clinical Studies
- •6.4.In Vitro Tests
- •6.4.1. Salmonella Typhimurium Reverse Mutation Test
- •6.4.2.Chromosomal Aberration Test
- •6.4.3. Sister Chromatid Exchange
- •2.2.2.1.4. Cytotoxicity Testing in the l-929 Mouse Fibroblast Cell Line
- •6.5.Short Term in vivo Tests
- •6.5.1. Intracutaneous Reactivity Study in the Rabbit
- •6.5.2. Acute Systemic Toxicity Study in the Mouse
- •6.5.3. Sensitization Study in the Guinea Pig (Maximization Method)
- •6.6.Long-term In Vivo Tests
- •2.3. Safety and Efficacy in Animals
- •2.3.1. Electromagnetic Compatibility
- •2.3.2. Stress Tests
- •6.7.Three-Point Bending Test
- •6.8.Impact Testing
- •2.4. Safety and Efficacy in Humans
- •2.4.1. Electrical Stimulation Using bioNs™ to Treat Shoulder Subluxation Soon After Stroke
- •6.9.Background
- •6.10.Trial Description
- •6.11.Preliminary Results
- •2.4.2. Electrical Stimualtion Using bioNs™ To Treat Muscular Hypotrophy In Individuals With Osteoarthritis
- •6.12. Background
- •6.13.Trial Description
- •6.14.Preliminary Results
- •2.5. Adverse information
- •7.Investigational plan
2.1.1.1.4. The Use of Tantalum in Medical Applications
Because of its desirable physiochemical properties and biocompatibility, tantalum has been used successfully as a material for implants in medicine for over thirty years. Tantalum has been used as a material for joint prostheses, bone replacements and repair, suture wire, cranial repair plates, and radiographic markers.
1. Issa, T.K., Bahgat, M.A., & Linthicum, F.H., Jr. (1983). Tissue reaction to prosthetic materials in human temporal bones. The American Journal of Otology,5, 40-43.
2. Grundshober, F., Kellner, G., Eschberger, J., & Plenck, H.J. (1980). Long-term osseus anchorage of endosseus dental implants made of tantalum and iridium. 1st World Biomaterials Congress, Baden, 365(abstract).
3. Kobayashi, H., Hayashi, M., Kawano, H., Handa, Y., Kabuto, M., & Tsuji, T. (1986). Treatment of blow-out fracture. Neurological Research, 8,221-224.
4. McFadden, J.T. (1989). Evolution of the crossed-action intracranial aneurysm clip. Technical note. Journal of Neurosurgery, 71, 293-296.
5. Strecker, E.P., Boos, I.B., & Hagen, B. (1996). Flexible tantalum stents for the treatment of iliac artery lesions: long-term patency, complications, and risk factors. Radiology, 199,641-647.
6. Strecker, E.P., Hagen, B., Liermann, D., Schneider, B., Wolf, H.R., & Wambsganss, J. (1993). Iliac and femoropopliteal vascular occlusive disease treated with flexible tantalum stents. Cardiovascular and Interventional Radiology,16(3), 158-164.
7. Ozaki, Y., Keane, D., Nobuyoshi, M., Hamasaki, N., Popma, J.J., & Serruys, P.W. (1995). Coronary lumen at six-month follow-up of a new radiopaque Cordis tantalum stent using quantitative angiography and intracoronary ultrasound. American Journal of Cardiology, 76, 1135-1143.
8. Gamsu, G., & Nadel, J.A. (1972). New technique for roentgenographic study of airways and lungs using powdered tantalum. Cancer,30, 1353-1357.
9. Zamel, N., Austin, J.H., Graf, P.D., Dedo, H.H., Jones, M.D., & Nadel, J.A. (1970). Powdered tantalum as a medium for human laryngography. Radiology, 94, 547-553.
10. Lawson, T.L., Margulis, A.R., Nadel, J.A., Rambo, O.N., & Wolfe, W.G. (1969). Intraperitoneal introduction of tantalum powder. A roentgenographic and
pathologic study. Investigative Radiology, 4, 293-300.
11. Gerstenberg, T .C., Praetorius, B., Nielsen, M.L., Clausen, S., & Lindenberg, S. (1983). Sterilization by vas occlusion without transection does not reduce postvasectomy sperm-agglutinating bodies in serum. A randomized trial of vas occlusion versus vasectomy. Scandinavian Journal of Urology & Nephrology, 17, 149-151.
12. Bjork, A. (1968). The use of metallic implants in the study of facial growth in children: method and application. American Journal of Physical Anthropology, 29, 243-254.
13. Bjork, A., Sarnas, K.V., & Rune, B. (1995). Intramatrix rotation--the frontal bone. European Journal of Orthodontics, 17, 3- 7.
14. Trope, C., & Selvik, G. (1997). Antineoplastic drug effect evaluated with a new X-ray stereographic measurement of the tumor volume. Current Chemotherapy, 1137.
15. Sarnat, B.G., & Selman, A.l. (1978). Growth pattern of the rabbit nasal bone region. a combined serial gross and radiographic study with metallic implants. Acta Anatomica (Basel), 101, 193.
16. Rubenstein, L.K., Strauss, R.A., Lindauer, S.l., Davidovitch, M., & Isaacson, R.l. (1993). Tantalum implants as markers for evaluating postoperative orthognathic surgical changes. International Journal of Adult Orthodontics & Orthognathic Surgery,8(3), 203-209.