Cervical And Spinal Stim – Noninvasive Pulsed Electromagnetic Bone Growth Stimulator By Orthofix

 [Note: On the Orthofix website there is a very similar product to the Cervical Stim called the Spinal Stim. However for this post, I will be primarily talking about the Cervical Stim Product]

Analysis & Interpretation:

The two products being sold, the Cervical Stim and the Spinal Stim operate on the same pulse electromagnetic field theory (PEMF) as the products we have seen before with other products which are supposed to be easily worn and cause accelerated bone non-union healing. There are a few PubMed studies cited which show that the pulsed electromagnetic fields generated can increase the mTOR level and increase osteogenic activity. The science is weak in proof and there are not enough studies done to show that E&M fields really cause faster bone healing, except from studies done in the 30s and 40s of the last century. The devices are easy to wear and comfortable but slightly on the expensive side.

Implications For Height Increase

While the cervical stim is supposed to be worn around the neck touching the cervical vertebrate, the spinal stim is supposed to be worn around the torso touching the thoracic vertebrates. Each can possible lead to some increased vertebrate lengthening if there is really a fracture in the vertebrate in the right direction. However the increase in any possible height would be negligible since the healing if it does cause accelerated bone growth and spinal fusion would cause the vertebrate to be slightly curved from one side of the vertebrate being having more bone thus stunting whatever few millimeters of height increase the device can give to that one side.


For the Cervical Stim product main page HERE

cervicalProduct Description

Cervical-Stim® offers the security of proven, safe and effective bone growth stimulation to significantly increase the rate of cervical fusion success in high-risk patients.

It offers the comfort of an external device that patients tell us is the most effortless treatment they have ever experienced. Not to mention the comfort enjoyed with improved clinical outcomes: In a PMA study of 323 high-risk ACDF patients, 84% achieved fusion within six months using Cervical-Stim vs. 69% for those who did not receive treatment. Additionally, the data from this study prove for the first time that fusion has a positive effect on VAS and NDI clinical outcomes after ACDF.

Since 1990, more than 200,000 spine fusion patients have healed with bone growth stimulation from Orthofix. We brought you the first and most effective external bone growth stimulator for lumbar fusion, and now offer you the only FDA approved device to increase the rate of cervical fusion success.

  • Comfortably worn during daily activities, with or without a cervical brace, four hours per day
  • Proven to overcome risk factors for nonfusion
  • Next generation design with smart technology and patient friendly functionality

Indication

The Cervical-Stim is a noninvasive, pulsed electromagnet bone growth stimulator indicated as an adjunct to cervical fusion surgery in patients at high risk for nonfusion.

Physician Benefits

  • Safe and effective bone growth stimulation to significantly increase the rate of cervical fusion success in high-risk patients
  • Smart technology can provide outcomes reports and hardcopy patient compliance monitoring
  • Written guarantee for bone growth stimulation products
  • The only FDA approved bone growth stimulator for cervical fusion
  • Patient friendly, comfortably worn during daily activities with or with a cervical brace, four hours per day

Clinical References:

  • Exposure of Murine Cells to Pulsed Electromagnetic Fields Rapidly Activates the mTOR Signaling Pathway. Patterson T et al. Bioelectromagnetics 27: 535-544, 2006. Science Sheet (PDF 174KB)
  • 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. Science Sheet (PDF 211KB)
  • 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. Science Sheet (PDF 129KB)
  • 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.

Patient Benefits

  • Lightweight, all-in-one unit allows unrestricted patient mobility – no separate cables, control units or battery packs
  • Comfortably worn around the neck, with or without a cervical brace, four 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.)

Contraindications

There are no known contraindications for the Cervical-Stim as an adjunct to cervical spine fusion surgery.

Warnings

  • The Cervical-Stim may interfere with the operation of a cardiac pacemaker or defibrillator. Consultation with the attending cardiologist is recommended
  • The Cervical-Stim should be removed prior to any imaging procedures (e.g., CT scan, MRI, etc.)

Precautions

  • The Cervical-Stim should not be used if there are mental or physical conditions that may preclude compliance with physician or device instructions
  • The Cervical-Stim has not been evaluated in treating patients with the following conditions: osseous or ligamentous spinal trauma, spondylitis, Paget’s disease, moderate to severe osteoporosis, metastatic cancer, renal disease, rheumatoid arthritis, uncontrolled diabetes mellitus, patients prone to vascular migraine headache, seizure, epilepsy, thyroid conditions or neurological diseases
  • Animal teratological studies performed with this device did not show any adverse effects in animals. However, the safety of this device for use on patients who are pregnant or nursing has not been established

Footnotes

  1. Results from Orthofix Inc. PMA Randomized, Prospective Controlled Clinical Trial of Pulsed Electromagnetic Field Stimulation for Cervical Fusion, 2004.
  2. Anterior Cervical Discectomy and Fusion: Correlation of Fusion Status with Clinical Outcome, Kevin Foley, M.D., Neurosurgery. Presented at the NASS 20th Annual Meeting, Philadelphia, PA

For the Spinal Stim product main page HERE

spinalstimProduct 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 surgery. Spinal-Stim offers:

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

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.

Physician Benefits

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

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.

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.)

 

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