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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.

PHYSIOSTIM

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.

Advantage of PhysioStim device

  • 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.*

  • Why do physicians prescribe a PhysioStim device?

  • High clinical success rates1-3
  • PEMF signal covers 360 degrees around the fracture site5
  • Ease of placement enables consistent treatment of the fracture site
  • Penetrates evenly across tissue, bone, and fixation4
  • STIM on Track mobile app enables physicians to remotely view patient adherence to prescribed treatments

* STIM onTrack mobile app is available as an accessory for US model devices only

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.

CONTRAINDICATIONS

Use of this device is contraindicated where the individual has synovial pseudarthrosis.

See Patient Manual for additional product labeling information

Support Materials
Footnotes
  • 1. PhysioStim PMA P850007, February 1986
  • 2. Garland DE, Moses B, Salver W. Fracture ​healing: Long-term follow-up of fracture nonunions treated with PEMFs. Contemp Orthop. 1991;22(3):295-302
  • 3. Orthofix patient registry. PMA P850007/S20. Data on file.
  • 4. Data on file. Field mapping analysis conducted by M. Zborowski, Ph.D., Cleveland Clinic.
  • 5. Navarro, M., Michiardi, A., Castano, O., & Planell, J.. (2008). Biomaterials in orthopaedics. Journal of the Royal Society Interface, 5(27), 1137-1158.

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