Bone Growth Stimulator - Spine

*Doctor prescription is needed from a Podiatrist, Orthopedic Surgeon or Spine Specialist, whether to process through health insurance plans or out-of-pocket self pay. REGENERATION SPINALOGIC® 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. Designed to be a lightweight device with cushion strap designed for maximum patient comfort. Can be applied over a cast, brace, or clothing. DJO’s more advanced technology to support patient use.28 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.   DESIGNED WITH PATIENT COMFORT IN MIND Lightweight device with custom strap for maximum patient comfort Can be applied over a brace or clothing Built in compliance tracking One button technology for ease of use Experienced customer service support team available to all patients Personalized service by highly trained account representatives available to size, fit and train patients   SCIENTIFICALLY RELEVANT Normal functional activity induces a range of low frequencies from 10 – 150Hz1 When studied, results proved that lower frequencies, similar to those generated intrinsically by functional activity produce the maximum bone cell response1 Resorption of bone is lowest and new bone formation is greatest when the power of the induced electrical field is concentrated in the very low frequency range.1 MORE ADVANCED TECHNOLOGY* 30 minute daily treatment can improve patient compliance29 21% increase in primary lumbar fusions over placebo device8 COMPANY TECHNOLOGY PMA DAILY WEAR TIME DJO® 1 Combined Magnetic Field (CMF™) 30 Minutes ZIMMER BIOMET™2 Capacitive Coupling 24 Hours ORTHOFIX®3 Pulsed Electromanetic Field 2-8 Hours 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 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. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. For full prescribing information, contact OrthoSTAT, Corp.