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Spinal-Stim® Osteogenesis Stimulator

Description

​​​​

PRODUCT DESCRIPTION​​

Spinal-Stim​​ has high success rates for spinal fusion. With an overall clinical success rate of 92 percent, Spinal-Stim provides a 36​ percent increase in lumbar fusion success when used adjunctively to surgery.1,2 Spinal-Stim is also the only osteogenesis stimulator approved as a non-surgical alternative for treating failed lumbar fusions.1,3 

​Product Highlights​

  • High success rates​ for spinal fusion​ (92 percent when used adjunctively to surgery)1,2
  • Only U.S. Food and Drug Administration (FDA) approved osteogenesis stimulator for non-surgically treating pseudarthrosis1,3
  • Pulsed electromagnetic f​ield (PEMF)​ treatment signal covers 360 degrees, up to five levels of fusion1,4
  • Works effectively when worn over clothing or bracing
  • Lightweight, all-in-one unit with no cords allows unrestricted patient mobility during treatment​
  • Built-in daily​ monitoring software to track patient compliance
  • Money-back guarantee​ that enables insurers to cover with confidence​*​

footnotes

  1. FDA PMA P850007/S6, February 1990
  2. Mooney V. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields of interbody lumbar fusions. Spine. 1990 July;15(7):708-12.
  3. Simmons JW, Mooney V, Thacker I. Pseudarthrosis after lumbar spine fusion: no​n-operative salvage with pulsed electromagnetic fields. American Journal of Orthopedics, 2004 Jan;33(1):27-30.
  4. Zborowski M, Midura RJ, Wolfman A, et al. Magnetic field visualization in applications to pulsed electromagnetic field stimulation of tissues. Annals of Biomedical Engineering. 2003 31 (1): 195-206​
*Money back guarantee does not apply to wholesale orders.

Indication

​Indication

Spinal-Stim is a non-invasive electromagnetic bone growth stimulator indicated as an adjunct to spinal fusion to increase the probability of fusion success and as a non-operative treatment of salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.

Contraindication​

Cardiac pacemakers may be adversely affected by exposure to PEMF. Use of this device is contraindicated where the individual has an implanted cardiac pa​cemaker.


See Patient​ Manual for additional product labeling information.

Clinical References

  • Barnes F, Greenebaum B. Biological and Medical Aspects of Electromagnetic Fields. CRC Press, 2007.
  • Foley KT, Mroz TE, Arnold PM, et al. Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion. Spine J. 2008;8(3):436-442
  • Ibiwoye MO, Powell KA, Grabiner MD. Bone mass is preserved in a critical-sized osteotomy by low energy pulsed electro­magnetic fields as quantitated by in vivo micro-computed tomography. J Orthop Res. 2004;22(5):1086-93
  • Marieb, Elaine N. Human Anatomy & Physiology. The Benjamin/Cummings Publishing, 1998.
  • Midura RJ, Ibiwoye MO, Powell, KA, et al. Pulsed electromagnetic field treatments enhance the healing of fibular osteoto­mies. J Orthop Res. 2005;23:1035-46
  • Mooney V. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions. Spine. 1990;15(7):708-712
  • Panagolous DJ, Karabarbounis AK, Margaritis LH. Mechanism for action of electromagnetic fields on cells. Biochem Biophys Res Commun. 2002;298:95-102
  • Patterson TE, Sakai Y, Grabiner MD, et al. Exposure of murine cells to pulsed electromagnetic fields rapidly activates the mTOR-signaling pathway. Bioelectromagnetics. 2006;27(7):535-44
  • PMA P030034. December 2004.
  • PMA P850007. February 1990.
  • Schnoke M, Midura RJ. Pulsed electromagnetic fields rapidly modulate intracellular signaling events in osteoblastic cells: comparison to parathyroid hormone and insulin. J Orthop Res. 2007;25(7):933-40
  • Selvamurugan N, Kwok S, Vasilov A, Jefcoat SC, Partridge NC. Effects of BMP-2 and pulsed electromagnetic field (PEMF) on rat primary osteoblastic cell proliferation and gene expression. J Orthop Res. 2007;25(9):1213-20
  • Simmons JW Jr, Mooney V, Thacker I. Pseudarthrosis after lumbar spine fusion: nonoperative salvage with pulsed electro­magnetic fields. Am J Orthop. 2004;33(1):27-30
  • Zborowski M, Kligman B, Midura RJ, et al. Decibel attenuation of pulsed electromagnetic field (PEMF) in blood and cortical bone determined experimentally and from the theory of ohmic losses. Ann Biomed Eng. 2006;34(6):1030-41
  • Zborowski M, Midura RJ, Wolfman A, et al. Magnetic field visualization in applications to pulsed electromagnetic field stimulation of tissues. Ann Biomed Eng. 2003;31(2):195-206

Resources

Instructions for Use