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

back to top

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

back to top

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

back to top

Physician Support Materials
Brochures:
Case Studies:
Animation:

back to top

Clinical References:
  • Treatment of Failed Posterior Lumbar Interbody Fusion (PLIF) of the Spine with Pulsing Electromagnetic Fields. Simmons J.W. Clin Orthop 193:127-132, 1985.
  • 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.
  • Fundamental and Practical Aspects of Therapeutic Uses of Pulsed Electromagnetic Field (PEMFs). Bassett, C.A. Crit Rev Biomed Eng 17(5):451-529, 1989.
  • 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.
  • Long-Term Follow-Up of Fracture Nonunions Treated with PEMFs. Garland, Douglas E., M.D., Moses, Barbara M.B.A., B.S.N., R.N., Salyer, William, M.D. Contemp Orthop 22(3):295-302, Mar 1991.
  • Beneficial Effects of Electromagnetic Fields. Bassett, C.A. J Cell Biochem 51(4):387-93, Apr 1993.
  • Pulsed Electromagnetic Fields: an Adjunct to Interbody Spinal Fusion Surgery in the High Risk Patient. Mooney, V. Surgical Technologies International II 405-410, 1993.
  • Electrical Stimulation and Spinal Fusion. Yuan HA. Perspectives in Neurological Surgery 7(2):77-90, 1996.
  • 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.
  • 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.
  • Outcomes after Posterolateral Lumbar Fusion with Instrumentation in Patients Treated with Adjunctive Pulsed Electromagnetic Field Stimulation. Bose, Bikash. Advances in Therapy 18(1), Jan/Feb 2001.
  • Application of Pulsed Electromagnetic Fields (PEMF) After Lumbar Interbody or Posterolateral Spinal Fusion Surgery In a Heterogenous Patient Population. Silver, RA. The Journal of Neurological and Orthopaedic Medicine and Surgery 21(2), 2001.
  • 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.
  • Bone Mass is Preserved in a Critical-Sized Osteotomy by Low Energy Pulsed Electromagnetic Fields as Quantitated by in vivo Micro-Computed Tomography. Ibiwoye Michael O. et al. Journal of Orthopaedic Research 1086-1093, 2004.
  • Cervical-Stim PMA Approval Letter received 12/23/2004.
  • Pulsed Electromagnetic Field Treatments Enhance the Healing of Fibular Osteotomies. Ronald J. Midura, Michael O. Ibiwoye, Kimerly A. Powell, Yoshitada Sakai, Todd Doehring, Mark D. Grabiner, Thomas E. Patterson, Maciej Zborowski, Alan Wolfman. Journal of Orthopaedic Research 1035-1046, 2005.
  • Exposure to Murine Cells to PEMF Rapidly Activates the mTOR Signaling Pathway. Patterson T et al. Bioelectromagnetics 27: 535-544, 2006.
  • Pulsed Electromagnetic Fields Rapidly Modulate Intracellular Signaling Events in Osteoblastic Cells: Comparison to Parathyroid Hormone and Insulin. Schnoke Matthew and Ronald J Midura. Journal of Orthopaedic Research 933-940, July 2007.
  • Effects of BMP-2 and Pulsed Electromagnetic Field (PEMF) on Rat Primary Osteoblastic Cell Proliferation and Gene Expression. Selvamurugan N et al. Journal of Orthopaedic Research 1213-1220, Sep 2007.
  • Randomized, Prospective, and Controlled Clinical Trial of Pulsed Electromagnetic Field Stimulation for Cervical Fusion. Foley Kevin T et al. The Spine Journal 8: 436-442, 2008.

back to top

Web Resources
  1. www.SpineStimulation.com - Orthofix Patient Education
  2. www.spineuniversity.com
  3. www.spine-health.com/
  4. www.simmonssurgicalsociety.org
  5. www.americanbacksoc.org
  6. www.spine.org

back to top

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.

back to top

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
  • Normally poses no issues when traveling through airport security (user should bring product manual with their PEMF device and turn the device off if it must be put through an airport x-ray scan.)

back to top

Patient Support Materials
Brochures:
Animation:

back to top

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

back to top

About Us | Investors | Innovation | Products | Health Professionals | Patients | Coding | Careers | Customer Service

© 2010 Orthofix Holdings Inc.