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Cervical-Stim® Osteogenesis Stimulator

Description

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PRODUCT DESCRIPTION​​

Cervical-Stim​​​ is the only osteogenesis stimulator approved by the U.S. Food and Drug Administration (FDA)​ as a noninvasive, adjunctive treatment option for cervical fusion.1 The device uses pulsed electromagnetic f​ield (PEMF) technology to increase fusion success in patients at high risk for non-​fusion. With an overall clinical success rate of ​84 percent, Cervical-Stim increases fusion success significantly​ by 22 percent​ when used adjunctively to surgery.1,2  ​​​

​​Product Highlights​​

  • The only osteogenesis stimulator approved by the FDA for use in cervical fusion1
  • Delivers broad PEMF​​ treatment coverage for multilevel fusions1
  • Works effectively when worn over clot​hing 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. ​​PMA P030034, December 2004
  2. Foley K, et al. randomized, prospective, and ​controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion. The Spi​ne Journal. 2008 May/June;8:436-442.  Full article available at PubMed.gov
*Money back guarantee does not apply to wholesale orders.

Indication

​Indication

Cervical-Stim is a non-invasive, pulsed electromagnetic bone growth stimulator indicated as an adjunct to cervical fusion surgery in patients at high-risk for non-fusion.​

Contraindication​

There are no known contraindications for Cervical-Stim as an adjunct to cervical spine fusion surgery.


See Patient Manual for add​itional 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