BIOMET® EBI BONE HEALING SYSTEM®

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BIOMET® EBI BONE HEALING SYSTEM®

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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.

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.

This is an insurance-only item. As a result, any attempted purchase of this item will be automatically canceled.

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