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CMF Signal Science

Most advanced technology in electrical bone stimulation.

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NASS

Evidence-based coverage recommendations to ensure continued provision of quality spine care.⁷

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New Published Data

97% of patients treated with DJO Spinalogic fused compared to 62% of patients that received no stimulation.⁴

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Non Invasive Solution

A peer reviewed published study showed that electrical stimulation was significantly more cost effective (P less than 0.01) at one-year post op when compared to no stimulation or ultrasound for the treatment of non-unions.⁵

Ryaby, J.T., et al., The Role of Insulin-like Growth Factor in Magnetic Field Regulation of Bone Formation, Bioelectrochemistry and Bioenergetics, 35: 87-91, 1994

Fitzsimmons RJ, Ryaby JT, Magee FP, Baylink DJ. IGF-II receptor number is increased in TE-85 osteosarcoma cells by combined magnetic fields. J Bone Miner Res. 1995 May;10(5):812-9.

Charles Sfeir, DDS, PhD, Lawrence Ho, Bruce A. Doll, DDS, PhD, Kodi Azari, MD, and Jeffrey O. Hollinger, DDS, PhD. Fractrue Repair. Bone Regeneration and Repair, Biology and Clinical Applications. 2005, XII, 398p

Raiszadeh, Ramin, et al. "Effectiveness of combined magnetic field bone growth stimulation on lumbar spinal fusion outcomes: a single center retrospective analysis comparing combined magnetic field to no-stimulation." International Journal of Research in Orthopaedics 6.3 (2020): 1. A retrospective study that utilized radiographic fusion criteria, included data from 4 surgeons, consisted of a heterogenous patient population and had minimum 6 months follow up.

Wu N, Lee YC, Segina D, Murray H, Wilcox T, Boulanger L. The economic impact of US patients With fracture non-union, Orthopedic Research and Reviews, 2013; 5:21–33

[PMA 910066] Phillips, Mark, et al. "The Use of Combined Magnetic Field Treatment for Fracture Nonunion: A Prospective Observational Study." Journal of Long-Term Effects of Medical Implants 26.3 (2016).

NASS coverage reccomendations: https://www.spine.org/coverage

Linovitz, Raymond J., et al. "Combined magnetic fields accelerate and increase spine fusion: a double-blind, randomized, placebo controlled study." Spine 27.13 (2002): 1383-1388.

Mcleod, Kenneth J., and C. T. Rubin. "The effect of low-frequency electrical fields on osteogenesis." J Bone Joint Surg Am 74.6 (1992): 920-9.

[P910066 / S005] Phillips, Mark, et al. "Use of Combined Magnetic Field Treatment for Fracture Nonunion." Journal of Long-Term Effects of Medical Implants 26.3 (2016).

Joel Russell, Sheila Sprague, Sam Harper, Michelle Green & Mohit Bhandari (2021) An early cost analysis of magnetic bone growth stimulation in England, Expert Review of Pharmacoeconomics & Outcomes Research, DOI: 10.1080/14737167.2021.1920402

Fitzsimmons RJ, Ryaby JT, Magee FP, Baylink DJ. Combined magnetic fields increased net calcium flux in bone cells. Calcified Tissue International. 1994;55(5):376-380. doi:10.1007/bf00299318

Aleem IS, Aleem I, Evaniew N, et al. Efficacy of electrical stimulators for Bone Healing: A meta-analysis of randomized sham-controlled trials. Scientific Reports. 2016;6(1). doi:10.1038/srep31724

Patient IFU Fracture

Cottrill E, Pennington Z, Ahmed AK, et al. The effect of electrical stimulation therapies on Spinal Fusion: A cross-disciplinary systematic review and meta-analysis of the preclinical and Clinical Data. Journal of Neurosurgery: Spine. 2019;32(1):106-126. doi:10.3171/2019.5.spine19465

Rami E, Rae S, John A. Increased spinal lumbar fusion with combined magnetic field (CMF) bone growth stimulation. Journal of Orthopedic Surgery and Techniques. 2020;3(1). doi:10.36959/453/526

Stippick TW, Sheller MR. Combined magnetic fields provide robust coverage for interbody and posterolateral lumbar spinal fusion sites. Medical & Biological Engineering & Computing. 2015;54(1):113-122. doi:10.1007/s11517-015-1319-2

Patient IFU Spine

Baumhauer Phillips M, Baumhauer J, Sprague S, Zoltan J. Use of Combined Magnetic Field Treatment for Fracture Nonunion. J Long Term Eff Med Implants. 2016;26(3):277-284. doi: 10.1615/JLongTermEffMedImplants.2016016818. PMID: 28134611.

Enovis™ CMF PMA: P910066/S005, May 1997
“Tough/Difficult fracture” defined per the following: Success rates obtained on fractures greater than 9 months post-injury; Mean time since initial injury = 29.3 months; Mean number of prior surgeries = 2.5.

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