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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. www.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
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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