Electrical Bone Growth Stimulation
About the Device
When a bone fractures, the body produces naturally occurring electric fields surrounding and within the fractured bone segments to stimulate repair. These naturally occurring internal electrical fields are a critical, biological signaling process necessary for bone to grow and heal normally.
The purpose in using a bone growth stimulator is to mimic the body’s own natural occurring signaling processes by the application of an external, electric field for patients who may be at risk of healing.
- There are multiple published clinical studies demonstrating the effectiveness of Pulsed Electromagnetic Field (PEMF) Stimulation1
- Upper Extremities - In one clinical study, heal rates as high as 92% were achieved when treating scaphoid nonunion fractures with Pulsed Electromagnetic Field (PEMF) Stimulation, which was found to be a reliable alternative method of treatment2,*
- Lower Extremities - In another clinical study, heal rates as high as 100% were achieved when treating fifth metatarsal nonunion fractures with Pulsed Electromagnetic Field (PEMF) Stimulation3,*
- The overall success rate in a 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. Each additional hour of PEMF treatment correlated significantly with a 6-day reduction in the time to heal (P<0.001).4,**
- In one in vitro pre-clinical study, Pulsed Electromagnetic Field (PEMF) Stimulation 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 Field (PEMF) Stimulation increased angiogenesis through endothelial release of FGF-26,***
How it Works
The Bone Healing System works by sending pulsed electrical impulses from the electronic controller to the treatment site via an external flexible treatment coil, which generates an electromagnetic field that surrounds the treatment site helping to mimic the body’s natural healing process.
Click here to download a copy of the patient brochures and manuals which contain information and answers to commonly asked questions.
The Bone Healing System is programmed to deliver a maximum of 270 therapeutic treatment periods. Zimmer Biomet recommends a therapeutic treatment period of 10 hours per day. A therapeutic treatment period is defined as a 10-hour treatment session accomplished either continuously or discontinuously in segments totaling 10 hours. Patients unable to treat on consecutive days will be able to treat non-consecutively within 400 days after the first one-hour treatment period. If the device is not used for a 12-hour period, the device’s treatment clock will automatically reset and be ready to deliver the next 10-hour therapeutic treatment period when next turned on.
Basic safety precautions should always be followed, including removal of the device prior to showering, bathing or swimming.
Healing outcomes may vary due to health, activity, risk factors or other medical conditions the patient may have. Not all patients are candidates for this medical device so it’s important to evaluate each patient prior to prescribing the device. Only a qualified health care professional can determine the appropriate treatment for each patient.
Frequently Asked Questions
A qualified healthcare professional must prescribe a Bone Healing System. The Bone Healing System is a non-invasive bone growth stimulator 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.
No. The use of a pacemaker or cardioverter with the Bone Healing System is contraindicated and not recommended.
Yes, the treatment coil can be placed over or on top of a boot, cast or bracing. Once the coil has been shaped, apply the coil around the treatment site. The treatment site should be centered within the coil.
An extremity band is an additional optional component that may be ordered through Customer Service. The extremity band allows the controller to be worn conveniently on the arm or leg.
MRI scans and procedures should not be performed until the Bone Healing System has been completely removed.
Use of the Bone Healing Stimulator System during pregnancy has not been evaluated; therefore, it is not recommended.
Insurance coverage varies depending on your patient's insurance plan. The Bone Healing System is generally recognized by Medicare, Medicaid, worker’s compensation as well as private and public health plans. Zimmer Biomet’s Patient Advocacy Group is available to assist your patients and discuss any questions regarding insurance coverage, deductibles and potential out-of-pocket expenses. Patients may contact our Patient Advocacy Group at 1-888-236-3652.
Zimmer Biomet Customer Care Representatives are ready to answer questions and can be reached at 1-800-526-2579, extension 6000.
Representatives are available from 8:30 am to 5:00 pm (EST), Monday through Friday. At other times, please leave a clear message for a return call by the next business day.
The Biomet® EBI® Bone Healing System
The Bone Healing System is a non-invasive, nonsurgical, medical device intended to treat a fracture nonunion, failed fusion or congenital pseudarthrosis.
- The Bone Healing System has been designed so that it’s convenient to use, comfortable to wear and may be applied on the skin, over a brace, or cast.
- It’s easy to operate and offers 12 flexible treatment coils to treat any fracture nonunion or failed fusion in the upper or lower extremities.
- Compliance monitoring consistently tracks treatment progress.
- Over 700,000 patients have been treated with the Bone Healing System.7
- The Bone Healing System is FDA approved and has more than 40 years of proven clinical use.8
Important Product Information
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 on the order of 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 inclusive of “all active electrical and non-active conductive/metallic implants”. Use of the Biomet® EBI® Bone Healing System on pregnant patients has not been evaluated; therefore, it is not recommended. MRI scans should not be performed on patients until the device system has been completely removed.
WARNINGS: Use of the Biomet® EBI® Bone Healing System for the spine and skull have not been evaluated.
PRECAUTIONS: Nonunion fractures with gaps in excess of 1.0 cm or the presence of fixation devices or instrumentation made from magnetic materials may compromise a successful treatment outcome.
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.
The SFLX Treatment Coil Placement Guide illustrates the suggested placement of coils for the most common types of fracture nonunion and failed fusion sites.
Introducing the Bone Healing System
Watch this short video to learn more about The Biomet® EBI® Bone Healing System
*The person depicted is this video herein is a paid actress and not a patient.
- Data on File: Bone Healing System Publication List_Dec 2019
- 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.
- 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.
- 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
- 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.
- 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.
- Data on File Zimmer Biomet – ZBDATA1_20
- Data on File Zimmer Biomet – P790002
*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.
EBI, LLC d/b/a Zimmer Biomet
Bone Healing Technologies
399 Jefferson Road
Parsippany, NJ 07054 USA
If you have any questions regarding The Biomet® EBI® Bone Healing System, please contact the Customer Service team at 1-800-526-2579 extension 6000. Zimmer Biomet Customer Service Representatives are available from 8:30 am to 5:00 pm (EST), Monday through Friday. At other times, please leave a clear message for a return call by the next business day.
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This material is intended for health care professionals. Distribution to any other recipient is prohibited.
For complete prescribing and product information, including indications, contraindications, warnings, and precautions, please refer to the Biomet® EBI® Bone Healing System Physician Manual and Package Insert or Patient Manual.