PhysioStim™ Device

Description

PhysioStim™ devices provide a safe and effective non-surgical treatment to improve nonunion fracture healing. These devices use a pulsed electromagnetic field (PEMF) signal to induce a low-level electrical field at the fracture site which stimulates bone healing.3-7

Feature & Benefits

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.

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 onTrackmobile 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 rates4,10,17
  • PEMF signal covers 360 degrees around the fracture site18
  • Ease of placement enables consistent treatment of the fracture site
  • Penetrates evenly across tissue, bone and fixation21
  • First-to-market accessory, providing a patient friendly mobile app*, with patient usage data and a daily treatment reminder

Part Number

Description

5202 PhysioStim device (small, wrist/hand/ankle/foot)
5303 PhysioStim device (large, wrist/hand/ankle/foot)
5313 PhysioStim device (clavicle)
5314 R/L PhysioStim device (shoulder)
5315 PhysioStim device (hip)

The PhysioStim Device

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.

Use of this device is contraindicated where the individual has synovial pseudarthrosis. Demand type pacemaker operation may be adversely affected by exposure to pulsed electromagnetic fields. The safety and effectiveness of this device has not been established for individuals lacking skeletal maturity or individuals with a nonunion secondary to, or in connection with, a pathological condition. The safety of this device for use on patients who are pregnant or nursing has not been established. Rare instances of reversible minor discomfort have been reported.

Full prescribing information can be found in product labeling (see Manual on Download tab) or call Customer Service at 800-266-6969

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

PhysioStimStim™ device instruction manual

References

*The results of preclinical studies may not be indicative of human clinical trials.

  1. Bassett, CA. Fundamental and practical aspects of therapeutic uses of pulsed electromagnetic fields (PEMFs). Crit Rev Biomed Eng. 1989; 17(5):451-529
  2. Yen-Patton GP, et al. Endothelial cell response to pulsed electromagnetic fields: stimulation of growth rate and angiogenesis in vitro. J Cell Physiol. 1988 Jan; 134(1): 37-46
  3. Zoltan, JD. Electrical Stimulation of Bone: An Overview. Seminars in Orthopaedics, Vol 1, No 4 (December), 1986: 242-252
  4. PMA P850007. February 1986.
  5. PMA P850007/S6. February 1990.
  6. PMA P030034. December 2004.
  7. 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
  8. 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
  9. 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
  10. 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. PubMed Abstract
  11. Simmons JW, Mooney V, Thacker I. Pseudarthrosis after lumbar spine fusion: non-operative salvage with pulsed electromagnetic fields. American Journal of Orthopedics, 2004 Jan;33(1):27-30. PubMed Abstract
  12. Mooney V. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields of interbody lumbar fusions. Spine. 1990 July;15(7):708-12. PubMed Abstract
  13. Foley K, et al. Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion. The Spine Journal. 2008 May/June;8:436-442. PubMed Abstract
  14. Zborowski M, Androjna C, Waldorff El, Midura RJ 2015 Comparison or therapeutic magnetic stimulation with electric stimulation of spinal column vertebrae. IEEE Transactions on Magnetics 51(12): #5001009, doi: 10.1109/TMAG.2015.2458297
  15. 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
  16. 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
  17. Orthofix patient registry. PMA P850007/S20. Data on file.
  18. Data on file. Field mapping analysis conducted by M. Zborowski, Ph.D., Cleveland Clinic.
  19. iData Research Inc., U.S. Market for Spinal Implants and VCF (iDATA_USSP15_RPT), iData Research Inc (www.idataresearch.net) 2015
  20. spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations.aspx