Biomet® EBI Bone Healing System®

Effective

  • There are multiple published clinical studies demonstrating the effectiveness of pulsed electromagnetic field stimulation (PEMF)1
  • Upper Extremities – In one clinical study, heal rates as high as 92% were achieved when treating scaphoid nonunion fractures with Pulsed Electromagnetic Fields (PEMF), which was found to be a reliable alternative method of treatment2,*
  • Lower Extremities – In one clinical study, heal rates as high as 100% were achieved when treating fifth metatarsal nonunion fractures with Pulsed Electromagnetic Fields (PEMF)3,*
  • The overall success rate in one follow-up-in-practice dose response study compared days of treatment time and average daily use with the Bone Healing System. Nonunions included tibia, tibia/fibula and scaphoid4,**
    • Statistical analysis in the same follow-up-in-practice dose response study, indicated an average of 76 Days Earlier Healing was achieved when patients treated >9 hours per day versus ≤3 hours per day, which demonstrated a 6 Day Reduction in time to heal for each additional hour of average daily PEMF stimulation, up to 10 hours of daily use4,**

Scientifically Proven

  • In one in vitro pre-clinical study, Pulsed Electromagnetic Fields (PEMF) simultaneously induced osteogenesis and upregulated the transcription of bone morphogenetic proteins (BMP) e.g., BMP-2 & BMP-45,***
  • In another in vivo and in vitro pre-clinical study, Pulsed Electromagnetic Fields (PEMF) increased angiogenesis through endothelial release of FGF-26,***

An Established Product

  • Over 600,000 Bone Healing Systems sold7
  • More than 40 years of proven clinical use8

Designed with Patients in Mind

  • 12 anatomically configured coils are available to treat the appendicular system
  • Compliance monitoring software – The Biomet EBI Bone Healing System contains embedded software that displays patient treatment data. This data is viewable on the device’s LCD screen or may be downloadable to a health care professional’s computer for reviewing, storage or printout, via the use of the Patient Compliance Data Download Software9

 

Indications 

The Biomet EBI Bone Healing System is indicated for the treatment of fracture nonunions, failed fusions, and congenital pseudarthrosis in the appendicular system. A nonunion is considered to be established when there are no visibly progressive signs of healing - P790002/S028.

 

Usage

The recommended daily treatment dosage is normally 10 hours per day. The maximum recommended therapeutic treatment period is nine months (approximately 270 days). This device system is a durable therapeutic electrical device 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 or impair the functioning of certain external, non-invasive and/or implanted, invasive active medical devices. Use of the Biomet EBI Bone Healing System on pregnant patients has not been evaluated; therefore, it is not recommended in these cases. MR unsafe – Not for MRI Use.

For complete prescribing information including contraindications, warnings, and precautions, please refer to the Biomet EBI Bone Healing System Physician Manual and Package Insert or Patient Manual PN1068220-00 or PN1068243-00 or call 1-800-526-2579 extension 6000.

Financial Disclaimer

In support of their research for or preparation of this work, one or more of the authors may have received remuneration from Zimmer Biomet.

  1. Data on File_Bone Healing System Publication List_Dec 2019
  2. Frykman GK, Taleisnik J, Peters G, et al. Treatment of nonunited scaphoid fractures by pulsed electromagnetic field and cast. J Hand Surg Am. 1986;11(3):344-349.
  3. Holmes GB, Jr. Treatment of delayed unions and nonunions of the proximal fifth metatarsal with pulsed electromagnetic fields. Foot Ankle Int. 1994;15(10):552-556.
  4. Murray HB, Pethica BA. 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
  5. Bodamyali T, Bhatt B, Hughes FJ, et al. Pulsed 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(2):458-461.
  6. Tepper OM, Callaghan MJ, Chang EI, et al. Electromagnetic fields increase in vitro and in vivo angiogenesis through endothelial release of FGF-2. FASEB J. 2004;18(11):1231-1233.
  7. Data on File Zimmer Biomet – ZBDATA1_20
  8. Data on File Zimmer Biomet – P790002
  9. Compliance Data Download Software User Manual - PN 1067778-01

 

*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% for patients studied in the US. The success rates for all investigative fracture types ranged from 57% to 89% - SSED P790002.

**Survival analysis of patient time to heal data demonstrated that increasing the average daily PEMF dose from 1 to 10 hours correlated with a 35% to 60% reduction in time to heal in nonunion fractures of the scaphoid, tibia & tibia/fibula, which is the basis of why daily PEMF treatment of 10 hours is recommended. The survival analysis, statistical analysis and dose-response relationship presented within this follow-up-in-practice study was not included in the original PMA approval.

*** Although not indicative of human clinical results, outcomes from pre-clinical research have been implicated in various models of bone repair.

Legal Manufacturer:

EBI, LLC d/b/a Zimmer Biomet
Bone Healing Technologies
399 Jefferson Road
Parsippany, NJ 07054 USA


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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.