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Biomet® EBI Bone Healing System

Clinically Effective

More published studies than any electrical bone growth stimulation device company on the market1
Heal rates as high as 92%2***
2 ½ months earlier healing3****
75% of Biomet customers are repeat prescribers4

Scientifically Proven

Pre-clinical studies state PEMF has a reproducible osteogenic effect in vitro and simultaneously induces naturally occuring BMP-2 and BMP-45,**
In vivo and in vitro pre-clinical studies demonstrated PEMF exposure more than doubled the rate of angiogenesis6,**

Cost Efficient

According to a published, peer-reviewed study, electrical stimulation was shown to be more cost efficient when compared to no stimulation or LIPUS for the treatment of nonunions7

INDICATIONS: The Biomet® EBI Bone Healing System - P790002/S028 is indicated for the treatment of fracture nonunions, failed fusions, and congenital pseudarthrosis in the appendicular system. 

 

USAGE:

These device systems are durable therapeutic electrical devices intended for single patient use only under a prescription. Federal Law (U.S.A.) restricts this device to sale by or order from a physician. Rx Only - Prescription Only - Single Patient Use Only - Not for Re-Sale or Re-Distribution - Do Not Reuse. 

 

CONTRAINDICATIONS:

Nonunion fractures in which a synovial pseudarthrosis (fluid filled gap) exists. Under certain conditions, electromagnetic stimulation could inhibit the output of some demand pacemakers or implantable defibrillators. Therefore, it is not recommended for patients with certain types of pacemakers or implantable defibrillators. Patients should be cautioned to avoid coming in close proximity to pacemaker or defibrillator wearers during stimulation. Use of these device systems on pregnant patients has not been evaluated; therefore, it is not recommended in these cases. 

 

For complete prescribing information including success rates, warnings, and precautions, please visit www.biomet.com/stimmanuals or call 1.800.526.2579

 

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References

  1. Data on file at Biomet Spine & Bone Healing Technologies, most published electrical bone growth studies as of 9/7/2012 including clinical, pre-clinical, in vitro and in vivo animal studies
  2. Frykman, G.K., Taleisnik, J., Peters, G., Kaufman, R., Helal, B., Wood, V.E., and Unsell, R.S. Treatment of nonunited scaphoid fractures by pulsed electromagnetic field and cast. J Hand Surg Am, 1986. 11(3): p. 344-9.*
  3. Murray, H and Pethica, B. Pulsed Electromagnetic Field (PEMF) Therapy and Fracture Management: An Analysis of the Time to Heal Data. 2012. Data on file at Biomet Spine and Bone Healing Technologies* 
  4. Data on file at Biomet Spine & Bone Healing Technologies
  5. Bodamyali T, Bhatt B, Hughes FJ,Winrow VR, Kanczler JM, Simon B, Abbott J, Blake DR and Stevens CR. Pulsing electromagnetic fields simultaneously induce osteogenesis and upregulate transcription of bonemorphogenetic proteins 2 and 4 in rat osteoblasts in vitro. BiochemBiophys Res Commun 250:458-461, 1998*, **
  6. Tepper, O.M., Callaghan, M.J., Chang, E.I., Galiano, R.D., Bhatt, K.A., Baharestani, S., Gan, J., Simon, B., Hopper, R.A., Levine, J.P., and Gurtner, G.C., Electromagnetic fields increase in vitro and in vivo angiogenesis through endothelial release of FGF-2. FASEB J., 2004. 18(11): p. 1231-3 *, **
  7. Wu, N., Lee, YC, Segina, D., Murray, H., Wilcox, T., Boulanger, L. Economic Burden of Illness Amonth U.S. Patients Experiencing Fracture Nonunion. Orthop Res and Reviews. 2013 Mar; 5:21-33* 

 

*FINANCIAL DISCLAIMER: In support of their research for or preparation of this work, one or more of the authors may have received, in any one year, outside funding or grants from Biomet, EBI, LLC or Biolectron, Inc. 

 

**PRECLINICAL DISCLAIMER: Following non invasive electrical stimulation, increases in multiple growth factors have been observed in various pre-clinical in vitro cellular and in vivo animal studies. Although not indicative of human clinical results, these factors have been implicated in various models of bone repair.

***The original PEMF clinical study which led to PMA approval in 1979 yileded an overall functional union success rate of 76%. 

**** 2 ½ months earlier healing when the device is used for 9 or more hours per day as compared to 3 or less hours per day.

 

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Biomet Orthopedics
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P.O. Box 587
Warsaw, Indiana 46581 USA

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For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and information on this website. To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 1-800-348-2759, press 4 for 411 Technical Support.