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Biomet? EBI Bone Healing System

Clinically Effective

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

Scientifically Proven

Pre-clinical studies demonstrate that PEMF stimulation has a reproducible osteogenic effect?in vitro?and simultaneously induces naturally occurring BMP-2 and BMP-45,**
In vivo?and?in vitro?pre-clinical research demonstrates PEMF stimulation increases angiogenesis more than twofold6,**

Cost-Effective

According to a published, peer-reviewed study, electrical stimulation was shown to be a cost-effective treatment for fracture nonunions7, *****

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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.?

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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.?

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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 review the Physician Manual and Package Insert or call 1.800.526.2579

Guides and Manuals

  1. Data on file at Zimmer Biomet, EBI, LLC, most published electrical bone growth studies as of 9/7/2012
  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):344-9.*
  3. Murray, H.B. and Pethica, B.A.? A follow-up study of the in-practice results of pulsed electromagnetic field therapy in the management of nonunion fractures. Orthop Res and Reviews, 2016. 8:67-72 *?
  4. Data on file at Zimmer Biomet, EBI, LLC
  5. Bodamyali, T., Bhatt, B., Hughes, F.J., Winrow, V.R., Kanczler, J.M., Simon, B., Abbott, J., Blake, D.R. and Stevens, C.R. Pulsing electromagnetic fields simultaneously induce osteogenesis and upregulate transcription of bone morphogenetic proteins 2 and 4 in rat osteoblasts in vitro. Biochem Biophys Res Commun, 1998. 250:458-461*, **
  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):1231-3 *, **
  7. Wu, N., Lee, Y., Segina, D., Murray, H., Wilcox, T., Boulanger, L. Economic burden of illness among US patients experiencing fracture nonunion. Orthop Res and Reviews, 2013. 5:21-33*?

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*FINANCIAL DISCLAIMER: In support of their research for or preparation of this work, one or more of the authors may have received financial remuneration from Zimmer Biomet, EBI, LLC or Biolectron, Inc.?

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**PRE-CLINICAL 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 under the supervision of C.A.L. Bassett, M.D., Sc.D. which led to PMA approval in 1979 yielded an overall functional union success rate of 76%.?

**** Patients who treated with PEMF stimulation for 9 or more hours per day healed on average 76 days earlier than patients who treated with PEMF stimulation for 3 or less hours per day.

***** This study measured actual health care resource utilization and did not assess clinical effectiveness or healing times.

Legal Manufacturer:

Zimmer Biomet, EBI, LLC
399 Jefferson Road
Parsippany, NJ 07054 USA


All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to Zimmer Biomet or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Zimmer Biomet. ?
This material is intended for health care professionals. ?Distribution to any other recipient is prohibited.
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.
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