Biomet Spine & Bone Healing Technologies

SpF® Implantable Spine Fusion Stimulator


A Proven Treatment for Posterolateral Lumbar Spine Fusions

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, DC stimulation enhances the expression of several different osteoinductive growth factors, including BMP-2, BMP-6, and BMP-7(5, *)

ECONOMICAL

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


© 2012 EBI, LLC. All rights reserved. All trademarks are the property of Biomet, Inc. or one of its subsidiaries unless otherwise indicated.