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Similar to 3727 - CMF Spine Science sell sheet_r12[1] (20)
3727 - CMF Spine Science sell sheet_r12[1]
- 1. Because Greater Compliance
Equals Better Outcomes
CMF SpinaLogic® 30 Minute Bone Growth Stimulator
Outstanding Results
• 100% coverage of lumbar spine, interbody
and posterolateral10
• 6” depth of penetration10
• Proven 49% increase in overall fusion rate
• Increased fusion success by 21% points1
Superior Patient Compliance
• 90% compliance rate4
• 30 minute full treatment time
• Simple one-button operation
- 2. CMF SPINALOGIC® BONE GROWTH STIMULATION BRIEF PRESCRIBING INFORMATION
INDICATION: 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 be adversely 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.
CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. For full prescribing information, contact DJO, LLC.
1Linovitz 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,
2Mooney V. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields of interbody lumbar fusions. Spine. 1990 July;15(7):708-12, 3Goodwin C, Brighton C, Guyer R, et al.
A Double-Blind Study of Capacitively Coupled Electrical Stimulation as an Adjunct to Lumbar Spinal Fusions. Spine. 1999 Nov;24(13):1349-1356, 4Data on File - DJO Global, 5See SpinaLogic Full Prescribing
Information, 6See Spinal-Stim Full Prescribing Information, 7See SpinalPak Full Prescribing Information, 8McLeod KJ, Rubin CT. The effect of low-frequency electrical fields on osteogenesis. The Journal of
Bone & Joint Surgery. 1992;74:920-929, 9Ryaby JT, Fitzsimmons RJ, Khin NA, et al. The role of insulin-like growth factor II in magnetic field regulation of bone formation. Bioelectrochemistry and Bioenergetics.
1994;35:87-91, 10Stippick TW, Sheller MR. Combined magnetic fields provide robust coverage for interbody and posterolateral lumbar spinal fusion sites. Medical & Biological Engineering & Computing. 2015
May; DOI 10.1007/s11517-015-1319-2, 11Zborowski M, Waldorff E. Modeling Spine Exposure to Inductive and Capacitive Coupling Therapeutic Electromagnetic/Electrical Fields Generated by Spinal Stimulation
Devices. Orthofix White Paper.
Unique Signal Technology
• Only CMF SpinaLogic Bone Growth Stimulators utilize state-of-the-art Combined Magnetic Field
(CMF) technology which increases both the specificity and potency of treatment9
• CMF signal does not diminish as it passes through skin, muscle, and fat
00-3727 Rev A©2015 DJO, LLC
DJO, LLC I A DJO Global Company
T 800.336.6569 D 760.727.1280 F 800.936.6569
1430 Decision Street I Vista, CA 92081-8553 I U.S.A.
DJOglobal.com
Benefits Behind the 30 Minute Solution
Accelerated Healing.
Proven Science. Patient Convenience
Combined
Magnetic Field
Pulsed
Electromagnetic Field
Capacitive
Coupling
Clinical Evidence of Healing Yes1
Yes2
Yes3
Consistent Use - Patient Compliance 90%4
65%2
No (16 hr. Avg.)3
Instructed Daily Treatment Time 30 Minutes5
2 Hours6
24 Hours7
Increased Specificity of Signal Yes8,9
No8,9
No8,9
PMA Daily Treatment Time 30 Minutes1
8 Hours2
24 Hours3
Functions Within Optimal Frequency Healing Range 100%8,9
0.1%8
N/A
Signal Field of Coverage Full10
Full11
Unspecified
Power Source - Recharge Battery Monthly5
Daily6
Daily7
Direct Skin Contact No5
No6
Yes7
PMA Average Age 571
382
453