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Physio-Stim® Osteogenesis Stimulator

Description

PRODUCT DESCRIPTION​​

Physio-Stim 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), Physio-Stim has high success rates for treating nonunion fractures.1,2 The device assists in fracture healing by delivering a pulsed electromagnetic field (PEMF) signal to the targeted fracture site.   ​

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Product Highlights

  • High clinical success rates (80 percent overall, up to 88 percent for gaps less than 3mm)1,2
  • Delivers broad PEMF treatment coverage around the fracture site1
  • Can be worn with internal and external fixation
  • Can be worn over casts (no windowing required)
  • Lightweight, all-in-one unit with no cords allows unrestricted patient mobility during treatment
  • Built-in daily​ monitoring software to track patient compliance
  • Variety of anatomic models to provide treatment at the targeted fracture site
  • Money back guar​antee that enables insurers to cover with confidence​​*

footnotes​

  1. Physio-Stim 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
*Money back guarantee does not apply to wholesale orders.

Indication

Indication

The Physio-Stim 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.

Contraindication

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


See Patient Manual for additional product labeling information

Clinical References

  • ​Barnes F, Greenebaum B. Biological and Medical Aspects of Electromagnetic Fields. CRC Press, 2007.
  • Bassett CAL: Critical reviews in Bio Med Eng 17: 451-529, 1989.
  • Crit Rev Biomed Eng. 1989;17(5):451-529.
  • 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
  • Ibiwoye MO, Powell KA, Grabiner MD. Bone mass is preserved in a critical-sized osteotomy by low energy pulsed electromagnetic fields as quantitated by in vivo micro-computed tomography. J Orthop Res. 2004;22(5):1086-93
  • Marieb, Elaine N. Human Anatomy & Physiology. The Benjamin/Cummings Publishing, 1998.
  • Midura RJ, Ibiwoye MO, Powell, KA, et al. Pulsed electromagnetic field treatments enhance the healing of fibular osteotomies. J Orthop Res. 2005;23:1035-46
  • Orthofix patient registry. PMA P850007/S20. Data on file.
  • Panagolous DJ, Karabarbounis AK, Margaritis LH. Mechanism for action of electromagnetic fields on cells. Biochem Biophys Res Commun. 2002;298:95-102
  • Patterson TE, Sakai Y, Grabiner MD, et al. Exposure of murine cells to pulsed electromagnetic fields rapidly activates the mTOR-signaling pathway. Bioelectromagnetics. 2006;27(7):535-44
  • PMA 850007. February 21, 1986.
  • Schnoke M, Midura RJ. Pulsed electromagnetic fields rapidly modulate intracellular signaling events in osteoblastic cells: comparison to parathyroid hormone and insulin. J Orthop Res. 2007;25(7):933-40
  • Selvamurugan N, Kwok S, Vasilov A, Jefcoat SC, Partridge NC. Effects of BMP-2 and pulsed electromagnetic field (PEMF) on rat primary osteoblastic cell proliferation and gene expression. J Orthop Res. 2007;25(9):1213-20
  • Spadaro J, Bergstrom W. In Vivo and In Vitro Effects of a Pulsed Electromagnetic Field on Net Calcium Flux in Rat Calvarial Bone. Calcif Tissue Int. 2002; 70:496-502
  • Yen-Patton GP, et al: J Cell Phys 134: 37-46, 1988.
  • Zborowski M, Kligman B, Midura RJ, et al. Decibel attenuation of pulsed electromagnetic field (PEMF) in blood and cortical bone determined experimentally and from the theory of ohmic losses. Ann Biomed Eng. 2006;34(6):1030-41
  • Zborowski M, Midura RJ, Wolfman A, et al. Magnetic field visualization in applications to pulsed electromagnetic field stimulation of tissues. Ann Biomed Eng. 2003;31(2):195-206
  • ​Zoltan: Seminars in Orthop. 1:4 242-252, 1986.​​

Resources

Instructions for Use