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PhysioStim™
Key Features
- The PhysioStim device has been approved by the FDA for the treatment of nonunion fractures.
- Designed for patient ease of use
- Works effectively when worn over clothing, casting or bracing
- Single-piece, cordless design allows for ease of placement and patient mobility
- The STIM onTrack™mobile app is patient-friendly and provides patients with a treatment calendar, therapy reminders, and additional educational resources.
Description
Orthofix PhysioStim™
The PhysioStim™ device provides a safe, non-invasive option for treating fractures that are difficult to heal. With an overall clinical success rate of 80 percent (up to 88 percent for fracture gaps less than 3mm), PhysioStim devices have high success rates for treating nonunion fractures. The device assists in fracture healing by delivering a pulsed electromagnetic field (PEMF) signal to the targeted fracture site.
The PhysioStim device has been approved by the FDA for the treatment of nonunion fractures.1,2 A nonunion is a fracture that has shown no visible signs of healing. 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. Typical prescribed treatment time is three hours per day. An LCD and audible alarm provide important feedback during treatment such as the operational status, treatment time remaining, battery capacity, etc.
Typical Indications
The PhysioStim device is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. 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).
