Biomet®  EBI®  Bone Healing System

A fracture nonunion is considered to be established when there are no visibly progressive signs of healing. Typically, fractured bone starts to heal after a fracture occurs or after a surgeon has re-aligned, reduced and/or set the fractured bone fragments back into alignment.

During the following weeks or months, new bone tissue forms and continues to grow. As long as the fractured bone fragments receive an adequate supply of blood and other bio-chemical induced nutrients, newly formed bone tissue will grow and fuse together into a solid remodeled, repaired bone. The majority of bone fractures heal normally.

A fracture nonunion is a serious medical complication and may occur when bone lacks adequate stability, weight bearing control, blood flow, or when there are other underlying medical conditions which impair normal healing.³

Pseudoarthrosis is defined as a “false joint” or break in the bone that fails to heal on its own and usually develops within the first two years of life; however, there have been reported cases diagnosed before birth as well as later in life.  When pseudoarthrosis is diagnosed before or is present at birth, it’s referred to as congenital pseudarthrosis and can cause a variety of complications over time. The exact cause is unclear. Some believe that after the fracture occurs, there is a lack of blood supply to the outer layer of bone which promotes normal healing. This lack of blood supply results in scar tissue that forms and covers the bone which hinders proper healing.

In most cases, surgical intervention is required to correct the pseudarthrosis; however, the affected bone is susceptible to re-fracture as this condition is challenging to treat. Due to the inherent difficulty involved, it’s likely that the healthcare professional will administer additional, adjunctive therapies to treat the pseudarthrosis in an attempt to promote healing.

The Bone Healing System works by sending pulsed electrical impulses from the controller to the treatment site via an external flexible treatment coil, which generates an electromagnetic field that surrounds the treatment site helping to mimic your body’s own natural healing process.  

The Bone Healing System is programmed to deliver a maximum of 270 therapeutic treatment periods. ZimVie 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 you may have.   Not all patients are candidates for this medical device so it’s important to speak with your doctor. Only a qualified health care professional can determine the appropriate treatment for each patient.

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 these devices 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.