Cervical-Stim^®—Advantages and Benefits

Surgeon's choice for patients at-risk of pseudarthrosis

Cervical-Stim is the only FDA-approved device designed for non-surgical and non-invasive adjunct therapy to promote cervical spine fusion. In fact, Cervical-Stim and Spinal-Stim are the most prescribed spine fusion stimulators available today. Both pulsed electromagnetic field (PEMF) stimulators produce a uniform, low-level electrical field that activates the body’s own repair mechanism to stimulate bone healing. The PEMF technology developed by Orthofix provides surgeons with both lumbar and cervical bone stimulation devices supported by ample scientific and clinical data.

Cervical IDE Study Outcome: At 6 months post-op, the PEMF group had a significantly higher fusion rate than the control group (83.6% vs. 68.6%, p=.0065).⁵

Orthofix Cervical-Stim bone growth stimulator

Cervical-Stim^®
Spine Fusion Stimulator

Advantages and Benefits

Broad coverage: 360-degrees; up to 5 levels
Overcomes spinal fusion risk factors
PEMF signal penetrates cervical collar and clothing
Lightweight: 1.5 pounds
Guarantee program
Insurance acceptance
Compliance monitoring prints chart copy
Rechargeable battery
All-in-one unit allows for unrestricted patient mobility

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1 iData Research, U.S. Market for Spinal Implants and VCF, 2010.

2 Mooney V. Pulsed Electromagnetic Fields: An Adjunct to Interbody Spinal Fusion Surgery in the High Risk Patient. Surgical Technology International II. 1993;405-10.

3 Bernard T. Repeat Lumbar Spine Surgery: Factors Influencing Outcome. Spine. 1993;18:2196-2200.

4 Martin B, et al. Reoperation Rates Following Lumbar Spine Surgery and the Influence of Spinal Fusion Procedures. Spine. 2007;32(3):382

5 Foley K., et al. Randomized, Prospective, and Controlled Clinical Trial of Pulsed Electromagnetic Field Stimulation for Cervical Fusion. The Spine Journal. 2008 May-Jun;8(3):436-42.

6 Bassett, CAL. Fundamental and Practical Aspects of Therapeutic Uses of Pulsed Electromagnetic Fields (PEMFs). Critical Reviews in Biomedical Engineering. 1989;17(5):451.

7 Barnes F, Greenebaum B. Biological and Medical Aspects of Electromagnetic Fields. CRC Press. 2007.

8 Panagolous DJ, Karabarbounis AK, Margaritis LH. Mechanism for action of electromagnetic fields on cells. Biochem Biophys Res Commun. 2002;298:95-102.

9 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.

10 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.

11 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.

12 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.

13 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.

14 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.

15 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

16 PMA P850007. February 1990.

17 PMA P030034. December 2004.

18 Mooney V. A Randomized Double-blind Prospective Study of the Efficacy of Pulsed Electromagnetic Fields of Interbody Lumbar Fusions. Spine. 1990;15(7):708-12.

19 Simmons JW Jr., Mooney V., Thacker I. Pseudarthrosis after lumbar spine fusion: non-operative salvage with pulsed electromagnetic fields. American Journal of Orthopedics. 2004;33(1):27-30.

20 Bose B. Outcomes after posterolateral lumbar fusion with instrumentation in patients treated with adjunctive pulsed electromagnetic field stimulation. Advances in Therapy. 2001;18(1):12-20, DOI: 10.1007/BF02850247.

21 Silver RA. Application of Pulsed Electromagnetic Fields (PEMF) After Lumbar Interbody or Posterolateral Spinal Fusion Surgery in a Heterogenous Patient Population. The Journal of Neurological and Orthopaedic Medicine and Surgery. 2001;21(2):51-62.

22 Marks RA. Spine fusion for discogenic low back pain: outcomes in patients treated with or without pulsed electromagnetic field stimulation. Advances in Therapy. 2000 Mar-Apr;17(2):57-67.

Updated on: 12/10/18

Statement of Indications
Spinal-Stim is a non-invasive electromagnetic bone growth stimulator indicated as an adjunct therapy 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.

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

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Cervical-Stim®—Advantages and Benefits

Surgeon's choice for patients at-risk of pseudarthrosis

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Cervical-Stim^®—Advantages and Benefits