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SpinalStim™
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 SpinalStim™
The SpinalStim™ device is FDA approved to be used after spinal fusion surgery or to be used to treat a failed fusion from a previous surgery. For complete prescribing information, please refer to the Instruction Manual.
This single-piece device is lightweight, flexible and portable, allowing freedom of movement during treatment. The typical prescribed treatment time is two hours per day. 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. The SpinalStim device has an overall success rate of 92% in treating spinal fusion surgery patients. In addition, the SpinalStim device can be used for treatment of a failed spinal fusion, reducing the need for a revision surgery.
Typical Indications
SpinalStim is a noninvasive electromagnetic bone growth stimulator indicated as a spinal fusion adjunct to increase the probability of fusion success and as a nonoperative treatment of salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.
- "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).
