Biomet Spine & Bone Healing Technologies

SpF® Implantable Spine Fusion Stimulator


Providing a Proven Solution when Medically Necessary

With the continued pressure from insurance carriers, hospitals, and other paying parties to reduce costs, the SpF® Implantable Spine Fusion Stimulator may help to reduce the overall costs associated with posterolateral lumbar spine fusion surgery by increasing the probability of fusion success rates, particularly in patients with specific risks.

ECONOMICAL

  • Cost-effective, particularly in multi-level fusions
  • CPT and ICD-9 Codes

Proven Clinical History

  • Over 100,000 implanted to date
  • 50% increase in fusion rates over autograft alone(1)
  • Significantly improves fusion success rates particularly in patients with specific risk factors(1, 2, 3, 4)

PROVEN TECHNOLOGY

  • In pre-clinical investigations, Direct Current (DC) stimulation enhances the expression of several different osteoinductive growth factors, including BMP-2, BMP-6, and BMP-7(5, *)
Providing a constant dose of electrical stimulation for approximately 6 months(6)

  • Kane, W.J. Direct current electrical bone growth stimulation for spinal fusion. Spine (Phila Pa 1976), 1988.13(3): p. 363-5.
  • Rogozinski, A. and Rogozinski, C. Efficacy of implanted bone growth stimulation in instrumented lumbosacral spinal fusion. Spine (Phila Pa 1976), 1996. 21(21): p. 2479-83.
  • Kucharzyk, D.W. A controlled prospective outcome study of implantable electrical stimulation with spinal instrumentation in a high-risk spinal fusion population. Spine (Phila Pa 1976), 1999. 24(5):p. 465-8;discussion 469.
  • Source: SpF® Implantable Spinal Fusion Stimulator Technical Monograph, BSP196276L 05/10.
  • Fredericks, D.C., Smucker, J., Petersen, E.B., Bobst, J.A., Gan, J.C., Simon, B.J., and Glazer, P. Effects of direct current electrical stimulation on gene expression of osteopromotive factors in a posterolateral spinal fusion model. Spine (Phila Pa 1976), 2007. 32(2): p. 174-81.
  • P850035/S020/S022/S031/S033 Approved FDA Trade Names: SpF® PLUS-Mini (60 µA/W), SpF® PLUS-Mini (60 µA/M) and SpF® XL llb Implantable Spinal Fusion Stimulator. Certain models of theSpF® Implantable Spinal Fusion Stimulator have approved trade names preceded with "EBI" designating the former sponsor and/or applicant.
* In vitro cellular and pre-clinical studies may not be indicative of human clinical outcomes.


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