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CervicalStim™
Key Features
- Works effectively when worn over clothing or bracing.
- Cordless design enables you to keep moving while healing.
- A patient friendly mobile app, STIM onTrack™, with patient usage data.
- Daily treatment reminder via the STIM onTrack™ mobile app.
Description
Orthofix CervicalStim™
The CervicalStim™ device has been approved by the FDA to be worn after cervical spine fusion surgery in patients at risk for non-fusion. Please refer to the Instruction Manual for complete prescribing information.
It is a single-piece device that is lightweight, flexible and portable, allowing freedom of movement during treatment. An LCD and audible alarm provide important feedback during treatment such as the operational status, treatment time remaining, battery capacity, etc.
This device utilizes Orthofix PEMF technology that provides 360 degrees of treatment coverage around the fusion site, covering up to five vertebral levels. The CervicalStim device has an overall success rate of 84% in treating patients with difficult fusions.
Typical Indications
CervicalStim is a non-invasive, pulsed electromagnetic bone growth stimulator indicated as an adjunct to cervical fusion surgery in patients at high-risk for non-fusion.
- "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).
