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Extremities – CMF OL1000
Key Features
- For noninvasive treatment of an established nonunion fracture acquired secondary to trauma, excluding all vertebrae and flat bone.
- Lightweight and comfortable
- Easy-to-use & Noninvasive
- Requires simple, one-button operation
- Device is worn for only 30 minutes per day
- Can be used with internal or external fixation or over a cast
- HCPCS E0747
Description
Extremities – CMF OL1000
For noninvasive treatment of an established nonunion fracture acquired secondary to trauma, excluding all vertebrae and flat bone.
Bone Growth Stimulators for Delayed Union of Fractures
CMF OL1000 Bone Growth Stimulators are portable, battery-powered medical devices indicated for use in the noninvasive treatment of an established nonunion fracture acquired secondary to trauma, excluding all vertebrae and flat bones.
Bone Growth Stimulation for Various Fracture Sites
Single and Dual Coil Stimulators are available in multiple sizes for fractures of short and long bones.
CMF Treatment
- This treatment has been shown in pre-clinical studies to help the body’s own healing process begin working.
- Clinical studies have shown an increased chance of healing of 60.7% in patients with nonunions that averaged 29.3 months from injury.
- Registry data on over 2300 patients reports a heal rate of 75.1%.
Typical Indications
Noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
- "CMF, the only bone stimulating technology with an FDA approved mechanism of action, up-regulates synergistic growth factor signals, specifically, intracellular calcium, calmodulin & IGF II - all key factors in the formation of bone." - Washinton State Health Technology Assessment of Bone Growth Stimulators, 2009).
- A multi-center, randomized, double blind study of 201 patients undergoing posterolateral lumbar spinal fusion without instrumentation reported a 64% success rate with CMF stimulation, versus 43% without (Linovitz et al., Spine 27:1383-9).
- Patients with Charcot foot neuroarthropathy who received CMF treatment were able to resume ambulation in less than half the time of controls (11.1 weeks versus 23.8), and often with less joint destruction and residual deformity (J Foot Ankle Surg.1998;37(6):510-5).
- Sales of bone stimulators, particularly the noninvasive spinal fusion stimulators, are climbing rapidly (Frost and Sullivan Research Report on “U.S. Bone Growth and Spinal Fusion Stimulators Markets”).
- A 2008 survey of orthopedic surgeons regarding treatment of complicated tibial fractures, found that almost half (45%) of those responding employed bone stimulators as part of their management strategy (ActaOrthop.2008;79(5):689-94).
