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Product Description

Spinal-Stim delivers the highest success rates in bone growth stimulation for spine fusion and nonoperative salvage. In fact, 92% of patients receiving Spinal-Stim adjunctively have achieved fusion success1. When treating failed fusion with Spinal-Stim, 67% of patients achieve successful fusion with no additional surgery2. Spinal-Stim offers:

  • Proven Field Coverage
  • Risk Factor Coverage
  • Guarantee Program
  • Insurance Acceptance
  • FDA Approved Models for Both Cervical and Lumbar Spine

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Indication

The Spinal-Stim is a noninvasive electromagnetic bone growth stimulator 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.1

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Surgeon Benefits
  • Proven Field Coverage
  • Risk Factor Coverage
  • Guarantee Program
  • Insurance Acceptance
  • Smart technology can provide outcomes analysis and hardcopy patient compliance monitoring

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Surgeon Support Materials
Brochures:
Case Studies:
Videos:

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Clinical References:
  • A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions. Mooney, V. Spine 15 (7): 708-712, 1990 Pub Med Abstract
  • The effect of pulsed electromagnetic fields on instrumented posterolateral spinal fusion and device-related stress shielding. Ito M, Fay LA, Ito Y, Yuan MR, Edwards WT, Yuan HA. Spine 15: 22(4):382-388, 1997 Pub Med Abstract
  • Spine fusion for discogenic low back pain: outcomes in patients treated with or without pulsed electromagnetic field stimulation. Marks R.A. Advances in Therapy 17(2):57-67, 2000 Pub Med Abstract
  • Treatment of failed posterior lumbar interbody fusion (PLIF) of the spine with pulsing electromagnetic fields. Simmons J.W. Clin Orthop 193:127-132, 1985. Pub Med Abstract
  • Beneficial effects of electromagnetic fields. Bassett, C.A. J Cell Biochem. 1993 Apr;51(4):387-93. Review. Pub Med Abstract
  • Fundamental and practical aspects of therapeutic uses of pulsed electromagnetic field (PEMFs). Bassett, C.A. Crit Rev Biomed Eng. 1989;17(5):451-529. Review. Pub Med Abstract
  • Endothelial cell response to pulsed electromagnetic fields: stimulation of growth rate and angiogenesis in vitro. Yen-Patton G.P, Patton W.F, Beer D.M, Jacobson B.S. J Cell Physiol 134(1):37-46, 1988 Pub Med Abstract
  • The effect of External Pulsed Electromagnetic Field Stimulation in Promoting Lumbar Fusion in a Rabbit Model. Ghanayem A.J., Stanwood W. Voronov L.I. , Havey R., and Patwardhan A.G.. North American Spine Society 16th Annual Meeting, Seattle Oct 31-Nov 3, 2001.
  • The effect of Pulsed Electromagnetic Fields on the Quality of Cage-Instrumented Lumbar Vertebral Fusion in the Ovine Model. Ghanayem A.J. and Larson M. North American Spine Society 16th Annual Meeting, Seattle Oct 31-Nov 3, 2001.
  • Clinical References Sorted by Individual Risk Factors to Fusion
  • Electrical stimulation and spinal fusion. Yuan HA.Perspectives in Neurological Surgery 7(2):77-90, 1996.
  • Pulsed electromagnetic fields: an adjunct to interbody spinal fusion surgery in the high risk patient. Mooney, V. Surgical Technologies International II, pg 405 - 410, 1993

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Part Reference Numbers
Part No. Description
2212 Spinal-Stim Bone Growth Stimulator

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Web Resources
  1. spineuniversity.com
  2. www.spine-health.com
  3. www.simmonssurgicalsociety.org
  4. www.americanbacksoc.org
  5. www.spine.org

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Patient Benefits
  • Lightweight, all-in-one unit allows unrestricted patient mobility - no separate cables, control units or battery packs.
  • Comfortably worn with or without a brace, two hours per day
  • Patient friendly functionality: Instant information panel with LCDs for ongoing operational status
  • Easy buckle for on/off
  • Designed for more flexibility and comfort
  • Internal countdown shuts off automatically when daily treatment is complete

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Patient Support Materials
*Patient manuals are for use outside of the U.S. only – not intended for distribution
Patient Manuals
Chinese (PDF 8.8MB) German (PDF 3.8MB)
Dutch (PDF 3.8MB) Italian (PDF 3.8MB)
English (PDF 3.8MB) Spanish (PDF 3.8MB)
French (PDF 3.8MB) Swedish (PDF 3.8MB)

Brochures:
Videos:

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Testimonials

Can you imagine not being able to pick up your four-year-old daughter due to back pain? I found that the Spinal-Stim actually supported my back, was comfortable and I could conceal it under a shirt if I wanted. I began wearing the Spinal-Stim every day and as a result, my surgeon advised me that I had healed more rapidly than expected. Thank you!
Jacque Grayson, Flint, Texas

On February 7, 2000, at Pennsylvania Hospital in Philadelphia a had spinal fusion and it has been a very successful recovery with no pain. I think that my Orthofix Spinal-Stim played a major role in my recovery along with a positive attitude and exercise. I am sorry it took me so long to let you know this. Thank you so much for your knowledge!
Brad A., Philadelphia, Pennsylvania

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Footnotes
  1. Spinal-Stim Summary of Safety and Effectiveness. P850007/S6. February 7, 1990. One-Year Postoperative Pre-Marketing Data From Randomized Double-Blind Placebo-Controlled Clinical Trial.
  2. Spinal-Stim Summary of Safety and Effectiveness. P850007/S6. February 7, 1990. One Year Follow-up, Pre-Marketing Data, Open Trial, Pseudoarthrosis Stratum Clinical Study.

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