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Important Safety Information

Spinal-Stim
Cervical-Stim
Physio-Stim

Orthofix is an established worldwide leader in PEMF (pulsed electromagnetic field) bone growth stimulation technology. Orthofix produces a full range of state-of-the-art medical devices for orthopaedics and neurosurgery that enhance the body's natural healing process, simulate natural function, protect, restore and heal.

You should consult with a licensed health care professional to determine what treatment may be appropriate for you.

Spinal-Stim

Clinical Success of the Spinal-Stim
The Spinal-Stim has been proven safe and effective in clinical studies. A randomized, placebo-controlled clinical study demonstrated a 92% success rate (fusion rate) with the adjunctive use of Spinal-Stim. An open clinical trial of patients who were diagnosed with failed spinal fusions (nonoperative salvage) demonstrated that application of Spinal-Stim resulted in a 67% success rate, meaning 67% of the patient population in this study healed without further surgery.

Contraindication
Cardiac pacemakers may be adversely affected by exposure to PEMF. Use of this device is contraindicated where the individual has an implanted cardiac pacemaker.

Warnings
• Although animal teratological studies performed with the device demonstrated no adverse findings, the safety of use of this device during pregnancy and nursing in humans has not been established.
• The safety and effectiveness of the use of this device on individuals lacking skeletal maturity have not been established.
• Animal studies conducted to date do not suggest any long-term adverse effects from the use of a similar device. However, long-term effects in humans are unknown.

Precautions
• This device should not be used if there are mental or physical conditions which preclude compliance with the physician and device instructions.
• This device 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, and uncontrolled diabetes mellitus.
• The results of premarketing data from the randomized double-masked cohort indicate that inconsistent users (defined as those patients that used the device for less than an average of two hours per day) had success rates similar to those in the placebo group. Therefore, the use of the device for less than the minimum recommended usage may result in lower success rates.

Adverse Events
Rare instances of reversible minor discomfort have been reported. They were: cumbersome or uncomfortable, minor tingling or pain, minor skin rash, insomnia, fainting, nausea/diarrhea, and polymenorrhea.

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Cervical-Stim

Clinical Success of the Spinal-Stim
In a Level 1 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.¹ For the first time, it was clinically proven that fusion has a positive effect on VAS and NDI clinical outcomes after ACDF.²

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

Warnings
• Do not use Cervical-Stim if you have a cardiac pacemaker or defibrillator because it may interfere with the operation of your pacemaker or defibrillator. If you use the Cervical-Stim and it affects your pacemaker or defibrillator, it may injure your heart. Consult your cardiologist.
• Remove the Cervical-Stim prior to any imaging procedures (e.g., CT scan, MRI, etc.). If you wear the Cervical-Stim during these procedures, you could be injured, the imaging being produced may be ruined, and/or the Cervical-Stim could be damaged.

Precautions
• Avoid using the Cervical-Stim if you do not understand the instructions your doctor has given you. If you use the Cervical-Stim incorrectly, it may harm you or may not help your healing process.
• 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 reproductive studies performed with this device did not show any harmful effects in animals. However, the safety of this device for use on patients who are pregnant or nursing has not been established.

Adverse Effects
Adverse effects may be experienced when using the Cervical-Stim. These adverse effects may include: increased pain, numbness and tingling, headache, migraines and nausea. These effects may or may not be directly related to the use of the Cervical-Stim. Any adverse effects that are related to the Cervical-Stim should stop when you discontinue use.

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

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Physio-Stim

Clinical Success of the Physio-Stim
The Physio-Stim has been proven safe and effective in clinical studies. In a prospective, multicenter, controlled clinical study for nonunion fractures, an overall success rate of 80% was demonstrated among 126 patients (135 nonunion fractures) who averaged greater than 3 hours of daily treatment. The average duration of nonunion in these difficult fractures was 2.6 years, with an average of 2.6 prior surgical procedures per fracture. The success rate of Physio-Stim treatment for nonunion repair demonstrated no statistically
significant change over long-term (four year) follow-up.

Contraindication
Use of this device is contraindicated where the individual has synovial pseudarthrosis.

Warnings
• The safety and effectiveness of the use of this device on individuals lacking skeletal maturity has not been established.
• In the presence of a malaligned nonunion, careful consideration of the use of this device must be undertaken on an individual basis, as treatment with this device is not intended to alter or affect the degree of malalignment.
• Demand type pacemaker operation may be adversely affected by exposure to pulsed electromagnetic fields. Physicians should not prescribe a Physio-Stim for application which may place the treatment transducer in close proximity to the pacemaker. Further screening by the attending cardiologist is recommended (such as with an electrocardiogram).
• Animal studies conducted to date do not suggest any long-term adverse effects from the use of this device. However, long-term effects in humans are unknown.
• The safety and effectiveness of this device on individuals with a nonunion secondary to, or in connection with, a pathological condition has not been established.

Precautions
• Nonunion fractures with gaps in excess of 1 centimeter (cm) have not been evaluated.
• Although animal reproductive studies performed with this device demonstrated no adverse findings, the safety of use of this device during pregnancy and nursing in humans has not been established.
• This device should not be used if there are mental or physical conditions which preclude patient compliance with physician and device instructions.

Adverse Effects
Rare instances of reversible minor discomfort have been reported. They were: cumbersome or uncomfortable, tingling or pain and minor skin rash.

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