NanoFUSE Bioactive Matrix

 
NanoFUSE Bioactive-DBM

NanoFUSE Bioactive Matrix

Advanced Bone Void Filler Implants


NanoFUSE® Bioactive Matrix is a new and unique demineralized bone matrix product that combines the osteoinductive capabilities of demineralized bone with the osteostimulative properties of 45S5 bioactive glass.


Results of animal studies conducted by both Amend Surgical and independent laboratories demonstrate that NanoFUSE® Bioactive Matrix performs better than other commercially available bone void filler implant preparations that include only DBM1. Using histopathological observation of ectopic bone growth, including the appearance of bone-forming cells, the presence of new bone, and new bone marrow provides excellent measures for comparison. Additionally, the calcium-based 45S5 bioactive glass, the first human made material to release calcium and form a direct chemical bond with tissue, allows production of an exceedingly strong interfacial bond between the graft and adjacent bony tissue within minutes2.

Bioactive glass has been shown to facilitate graft containment at the operative site as well as activate cellular osteogenesis3. Demineralized allograft bone supports cell attachment and proliferation and has shown the potential to induce bone formation. NanoFUSE® Bioactive Matrix offers surgeons the synergistic combination of bioactive glass and demineralized allograft bone in a single product.

The original formulation of 45S5 bioactive glass was invented in 1971 (Hench, et al). The capacity for rapid interfacial bonding, which is the defining characteristic of a bioactive material, is the result of chemical reactions that take place on the surface of bioactive glass when it is exposed to bodily fluids. This rapid bone bonding ensures positional stability of the graft during the critical period immediately following surgery. The ability of bioactive glass to rapidly bond with native tissue and trigger the cellular process of healing has prompted its use in an increasing number of clinical settings. NanoFUSE® Bioactive Matrix is currently indicated for use in general orthopedic and spine procedures.

Indications for Use:

NanoFUSE® Bioactive Matrix 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 (i.e., the extremities, pelvis and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NanoFUSE® Bioactive Matrix must be used with autograft as a bone graft extender in the posterolateral spine. The product provides a bone graft substitute that remodels into the recipient’s skeletal system.

NanoFUSE® Bioactive Matrix has a history of safe and effective clinical use. Biocompatibility testing and in vitro bench testing was conducted to evaluate the biological safety and performance characteristics of the device formulation. The performance of NanoFUSE® Bioactive Matrix in the extremities and posterolateral spine was evaluated in vivo4.


Osteoconductive, Osteoinductive and Osteopromotive Solutions

A synergistic combination of BioActive Glass and Demineralized Bone

Attach & Contain

The high ionic content of bioactive glass produces an exceedingly strong interfacial bond between the graft and adjacent bony tissue within minutes5. The capacity for rapid interfacial bonding, which is the defining characteristic of a bioactive material, is the result of chemical reactions that take place on the surface of bioactive glass when it is exposed to body fluids. This rapid bone bonding ensures positional stability of the graft during the critical period immediately following surgery6.

Signal & Protect

The three dimensional matrix of bioglass particles rapidly bond with native tissue to facilitate and promote the attachment of osteoblasts, fibroblasts and precursor cells necessary for bone regeneration. The osteostimulative benefits result in new bone formation throughout defect, not just at the margins as seen with passive osteoconductive implant options7. Additionally, in vitro studies demonstrate that ionic release (Ca++) and local pH changes inherent to bioactive glass create an unfavorable environment for growth of certain microbes.8

Activate & Amplify

NanoFUSE® Bioactive Matrix contains demineralized bone that is 100% tested for osteoinductive potential. The native proteins in demineralized bone have been shown to bind to mesenchymal stem cell receptors resulting in their proliferation and differentiation into osteoblasts and subsequent osteogenesis.9

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References:

1. Kirk T. J, (2012) Osteoconductivity and osteoinductivity of NanoFUSE® DBM.  Cell Tissue Bank DOI 10.1007/s10561-012-9297-1
2. Oonishi H, Kushitani S, Yasukawa E, Iwaki H, Hench LL, Wilson J, Tsuji E, Sugihara T (1997) Particulate bioglass compared with hydroxyapatite as a bone graft substitute. Clin Orthop Relat Res 334:316–325
3. Kirk T. J, (2012) Osteoconductivity and osteoinductivity of NanoFUSE® DBM.  Cell Tissue Bank DOI 10.1007/s10561-012-9297-1
4. BervenS, TayBK, KleinstueckFS, Bradford DS(2001)Clinical applications of bone graft substitutes in spine surgery: consideration of mineralized and demineralized preparations and growth factor supplementation. Eur Spine J 10(Suppl 2):S169–S177. doi:10.1007/s005860100270

5. Hench LL, Paschall HA (1973) Direct chemical bond of bioactive glass-ceramic materials to bone and muscle. J Biomed Mater Res 7(3):25–42. doi:10.1002/jbm.820070304
6. Hench LL, Paschall HA (1973) Direct chemical bond of bioactive glass-ceramic materials to bone and muscle. J Biomed Mater Res 7(3):25–42. doi:10.1002/jbm.820070304
7. Mulliken JB, Glowacki J, Kaban LB, Folkman J, Murray JE (1981) Use of demineralized allogeneic bone implants for the correction of maxillocraniofacial deformities. Ann Surg 194(3):366–372
8. 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.
9. Mulliken JB, Kaban LB, Glowacki J (1984) Induced osteogenesis—the biological principle and clinical applications. J Surg Res 37(6):487–496

Consistent handling and delivery characteristics

Utilizing a patent protected method of precipitating a gelatin onto the bioactive glass and demineralized bone matrix, NanoFuse Bioactive Matrix offers ease of preparation and shaping for filling of osseous defects.

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