Bone Growth Stimulation for Fracture and Spinal Fusion Patients

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Bone Growth Stimulation Resources for Fracture and Spinal Fusion Patients

Patient Resources

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Physio-Stim Limited Guarantee
Spinal-Stim Limited Guarantee
Cervical-Stim Limited Guarantee

Instruction Manual
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Quick Guide
Patient Guide to Insurance Coverage
Patient Q & A
Patient Q & A (Spanish)
Fracture healing: Long-term follow-up of fracture nonunions treated with PEMFs
Instruction Video

Instruction Manual
Limited Guarantee
Quick Guide
Patient Guide to Insurance Coverage
Patient Q & A
Patient Q & A (Spanish)
Randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields of interbody lumbar fusions
Instruction Video

Instruction Manual
Limited Guarantee
Quick Guide
Patient Guide to Insurance Coverage
Patient Q & A
Patient Q & A (Spanish)
Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion
Instruction Video

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Physio-Stim^®

The Physio-Stim^® is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

Use of this device is contraindicated where the individual has synovial pseudarthrosis. Demand type pacemaker operation may be adversely affected by exposure to pulsed electromagnetic fields. The safety and effectiveness of this device has not been established for individuals lacking skeletal maturity or individuals with a nonunion secondary to, or in connection with, a pathological condition. The safety of this device for use on patients who are pregnant or nursing has not been established. Rare instances of reversible minor discomfort have been reported.

Spinal-Stim^®

The Spinal-Stim^® is 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.

Cardiac pacemakers may be adversely affected by exposure to pulsed electromagnetic fields. Use of this device is contraindicated where the individual has an implanted cardiac pacemaker. The safety and effectiveness of this device has not been established for individuals lacking skeletal maturity. The safety of this device for use on patients who are pregnant or nursing has not been established. Rare instances of reversible minor discomfort have been reported.

Cervical-Stim^®

The Cervical-Stim^® is indicated as an adjunct to cervical fusion surgery in patients at high risk for non-fusion; there are no known contraindications.

Do not use this device if you have a cardiac pacemaker or defibrillator. Remove the device prior to any imaging procedures. The safety of this device for use on patients who are pregnant or nursing has not been established. Adverse effects may include increased pain, numbness and tingling, headache, migraines and nausea; these effects may or may not be directly related to use of the device.

Full prescribing information can be found in product labeling or by calling Patient Services at 1-800-535-4492.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

© 2015 Orthofix Holdings, Inc.