SpinalStim™ Device

SpinalStim™ Device
Description

The SpinalStim device is the only bone growth stimulation therapy approved by the FDA as both a lumbar spinal fusion adjunct and as a non-surgical treatment for spinal pseudarthrosis.

Features & Benefits

This single-piece device is lightweight, flexible and portable, allowing freedom of movement during treatment. The typical prescribed treatment time is two hours per day. An LCD and audible alarm provide important feedback during treatment such as the operational status, treatment time remaining, battery capacity, etc.

Designed for patient ease of use

  • Works effectively when worn over clothing or bracing
  • Cordless design enables you to keep moving while healing
  • A patient friendly mobile app, STIM onTrack™, with patient usage data*
  • Daily treatment reminder via the STIM onTrack™ mobile app*

This device utilizes Orthofix PEMF technology that provides 360 degrees of treatment coverage around the fusion site.14 The SpinalStim device has an overall success rate of 92% in treating spinal fusion surgery patients.5, 11, 12 In addition, the SpinalStim device can be used for treatment of a failed spinal fusion, reducing the need for a revision surgery.5,11

Why do physicians prescribe a SpinalStim device?

  • High clinical success rates5, 11, 12
  • Statistically significant results for patients who smoke or have a multi-level fusion5, 11, 12
  • PEMF signal covers 360 degrees around the fusion site14
  • Coverage up to 5 vertebral levels14
  • Supported by the North American Spine Society’s coverage recommendations20

Part Number

Description

5212 SpinalStim™ device

The SpinalStim Device

The SpinalStim device is indicated as a spinal fusion adjunct to increase the probability of fusion success and as a nonoperative treatment of salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.

Cardiac pacemakers may be adversely affected by exposure to pulsed electromagnetic fields. Use of this device is contraindicated where the individual has an implanted cardiac pacemaker. The safety and effectiveness of this device has not been established for individuals lacking skeletal maturity. The safety of this device for use on patients who are pregnant or nursing has not been established. Rare instances of reversible minor discomfort have been reported.

Full prescribing information can be found in product labeling (see Manual on Download tab) or call Customer Service at 800-266-6969

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

SpinalStim™ device instruction manual

References

*The results of preclinical studies may not be indicative of human clinical trials.

  1. Bassett, CA. Fundamental and practical aspects of therapeutic uses of pulsed electromagnetic fields (PEMFs). Crit Rev Biomed Eng. 1989; 17(5):451-529
  2. Yen-Patton GP, et al. Endothelial cell response to pulsed electromagnetic fields: stimulation of growth rate and angiogenesis in vitro. J Cell Physiol. 1988 Jan; 134(1): 37-46
  3. Zoltan, JD. Electrical Stimulation of Bone: An Overview. Seminars in Orthopaedics, Vol 1, No 4 (December), 1986: 242-252
  4. PMA P850007. February 1986.
  5. PMA P850007/S6. February 1990.
  6. PMA P030034. December 2004.
  7. 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
  8. 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
  9. 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
  10. Garland DE, Moses B, Salver W. Fracture healing: Long-term follow-up of fracture nonunions treated with PEMFs. Contemp Orthop. 1991;22(3):295-302. PubMed Abstract
  11. Simmons JW, Mooney V, Thacker I. Pseudarthrosis after lumbar spine fusion: non-operative salvage with pulsed electromagnetic fields. American Journal of Orthopedics, 2004 Jan;33(1):27-30. PubMed Abstract
  12. 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. PubMed Abstract
  13. Foley K, et al. Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion. The Spine Journal. 2008 May/June;8:436-442. PubMed Abstract
  14. Zborowski M, Androjna C, Waldorff El, Midura RJ 2015 Comparison or therapeutic magnetic stimulation with electric stimulation of spinal column vertebrae. IEEE Transactions on Magnetics 51(12): #5001009, doi: 10.1109/TMAG.2015.2458297
  15. 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
  16. 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
  17. Orthofix patient registry. PMA P850007/S20. Data on file.
  18. Data on file. Field mapping analysis conducted by M. Zborowski, Ph.D., Cleveland Clinic.
  19. iData Research Inc., U.S. Market for Spinal Implants and VCF (iDATA_USSP15_RPT), iData Research Inc (www.idataresearch.net) 2015
  20. spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations.aspx