CMF SPINALOGIC®

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CMF SPINALOGIC®

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Product Specifications

Combined Magnetic Field for accelerated spine fusion.

CMF SpinaLogic is a portable, battery-powered, micro-controlled, noninvasive bone growth stimulator indicated as an adjunct electromagnetic treatment to primary lumbar spinal fusion surgery for one or two levels.

Lightweight device with cushion strap designed for maximum patient comfort.
Can be applied over a cast, brace, or clothing.
Most advanced compliance technology to support patient use.9
One button technology for ease of use.
Experienced customer support team available to all patients.
Personalized service by highly trained account representatives available to size, fit and train patients.

Contact a Sales Representative for more information.

30 MINUTES USE PER DAY

The MOST current electrical bone growth stimulation technology.1

The MOST relevant scientific evidence.2

The MOST clinically effective electrical stimulator at 30 minutes use per day.3

DJO global’s CMF bone growth stimulator offers the most current electrical bone healing technology on the market.4

CMF technology entered the bone healing market in March of 1994 at 30 minutes wear time per day.
The most current electrical technology means that researchers used previous technologies in order to optimize the signal used for bone healing.
Several other electrical technologies require longer wear time to achieve successful results.
CMF operates within the optimal range for bone healing, meaning that patients need only wear their device for 30 minutes per day to achieve clinical benefits.

Scientific evidence supporting CMF is often considered the MOST relevant…

After testing multiple hypotheses, researcher determined that maximum bone cell response occurred within frequencies similar to those generated intrinsically by functional activity.

The noted, “Resorption of bone is lowest and new-bone formation is greatest when the power of the induced electric fields is concentrated in the very low-frequency range”
( 15Hz -150Hz).5

Further research in various frequencies impact on bone cell response showed the optimal frequency for bone healing to be 76.6Hz, the frequency now offered by the CMF bone growth stimulator system.6

Just 30 minutes exposure to 76.6Hz increased the volume and number of IGF II molecules and receptors. An increase in both have been correlated to an amplified increase in bone cell proliferation.

CMF Spinalogic has been proven to accelerate spinal fusion

CMF Technology is the MOST clinically effective electrical bone growth stimulator at 30 minutes per day.7

The ONLY technology proven to accelerate spine fusion in one simple, 30 minute treatment per day.

With just one 30 minute treatment per day, the CMF Spinalogic provided (please see diagram to the left)

INDICATIONS

CMF SpinaLogic® is a portable, battery powered, microcontrolled, noninvasive bone growth stimulator indicated as an adjunct electromagnetic treatment to primary lumbar spinal fusion surgery for one or two levels.

CONTRAINDICATIONS

Demand-type pacemaker and implantable cardiovertor defibrillator (ICD) operation may beadversely affected by exposure to combined static and dynamic magnetic fields. Physicians should not prescribe CMF SpinaLogic for patients with such devices. The safety and effectiveness of CMF SpinaLogic in pregnant women have not been studied, and the effects of the device on the mother or the developing fetus are unknown. Thus, this device should not be used in pregnant women. If a woman becomes pregnant during treatment with CMF SpinaLogic, treatment should be discontinued immediately.

PRECAUTIONS

The safety and effectiveness of the use of this device on individuals lacking skeletal maturity have not been established. The safety and effectiveness of this device in treating patients with the following conditions have not been established and therefore the safety and effectiveness of the device in these individuals are unknown: osseous or ligamentous spinal trauma, spondylitis, Paget’s disease, severe osteoporosis, metastatic cancer, renal disease, and uncontrolled diabetes mellitus. Animal studies conducted to date do not suggest any long term adverse effects from use of this device. However, long term effects in humans are unknown. Compliance with the treatment schedule, timely battery change and proper care of the device are essential. The device will not perform properly and treatment may be unnecessarily prolonged if the patient fails to adhere to the care routine. This device should not be used if there are mental or physical conditions which preclude patient compliance with the physician and device instructions.

ADVERSE EFFECTS

No known significant adverse effects have resulted from the use of this device. Clinical studies, animal studies, and tissue culture experiments conducted with CMF SpinaLogic Bone Growth Stimulator magnetic fields have not indicated any evidence of significant adverse effects.

References

Based on comparison of FDA approval dates for all electrical stimulators.
Based on and compared to all evidence supporting 30 minutes CMF weartime.
CMF OL1000 is the only electrical stimulation technology indicated for 30 minutes use in the noninvasive treatment of an established nonunion fracture acquired secondary to trauma, excluding all vertebrae and flat bones.
Dates represent first FDA approval of technology – technology may have been approved for other products at later dates. ⁵McLeod, K.J., Rubin, C.T., The Effect of Low Frequency Electrical Fields on Osteogenesis. J. Bone Joint Surg., 74A: 920 – 929, 1992.
Ryaby, J.T., et al., The Role of Insulin-like Growth Factor in Magnetic Field Regulation of Bone Formation, Bioelectrochemistry and Bioenergetics, 35: 87-91, 1994.
The only technology approved and with clinical evidence at 30 minutes per day.
Linovitz R, Pathria M, Bernhardt M, et al. Combined Magnetic Fields Accelerate and Increase Spine Fusion: A Double-Blind, Randomized, Placebo Controlled Study, Spine. 2002 July; 27(13):1383-1388. ⁹NASS Coverage Policy Recommendations for Electrical Bone Growth Stimulators, 2016.

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