Bone Healing
Biomet® EBI® Bone Healing System
Overview
About the Device
Physicians may prescribe a bone growth stimulator to aid in the bone healing process. The Biomet® EBI® Bone Healing System is a class III, FDA approved, nonsurgical bone growth stimulation device designed as an adjunctive therapy to aid in the healing of nonunion fractures, failed fusions, and congenital pseudarthrosis. Powered by Pulsed Electromagnetic Field (PEMF) technology, the Bone Healing System induces the body’s natural healing mechanisms to safely and effectively promote bone growth at the targeted treatment site.
Features & Benefits
Small, non-surgical device encourages patients to treat at their leisure
The 12 flexible, hand-crafted, therapeutic treatment coil options provide complete, 360-degree coverage around the treatment site
Therapeutic treatment coils may be worn over clothing, bracing, or a cast
Powered by pre-clinically proven Pulsed Electromagnetic Field technology
Clinically proven improved clinical outcomes
How the EBI® Bone Healing System Works
The Bone Healing System delivers safe and clinically proven pulsed electromagnetic field stimulation through a complete complement of flexible treatment coils. A pre-selected treatment coil is placed directly over the targeted treatment site, providing complete therapeutic coverage to achieve optimal healing outcomes. The area within and around the treatment coil is stimulated inducing the body’s natural healing mechanisms to safely and effectively promote bone growth at the targeted treatment site.
How to Use the EBI® Bone Healing System
The EBI® Bone Healing System is simple to set up and easy to use.
Conditions Treated with the Bone Healing System
Nonunion fractures
Failed fusions
Congenital pseudarthrosis
Clinical Effectiveness & FDA Approval
The EBI® Bone Healing System is supported by pre-clinical research and published clinical studies demonstrating the safety and effectiveness in improving bone healing outcomes.
The EBI® Bone Healing System has demonstrated an overall (clinical and radiographic) success rate at 90% for tibia, tibia/fibula and scaphoid nonunion fractures.1+
Device Specifications
Technology: Pulsed Electromagnetic Field (PEMF)
Signal: 15Hz
Delivery Method: Flexible treatment coils
Device Weight: 6.70 oz.
Original FDA Approval Date: 1979
Is the Bone Healing System Right for You?
The EBI® Bone Healing System is ideal for patients with fracture nonunions, failed fusions, or congenital pseudarthrosis.
The device requires a prescription by a licensed physician as part of a comprehensive fracture management plan, and is designed for patients that could benefit from non-surgical adjunctive treatment to support bone healing.
Frequently Asked Questions
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 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 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 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.
PATIENTS
If you have additional questions regarding your doctor’s instructions in using this device, or you are experiencing any type of adverse reaction with the use of this device, contact your doctor immediately. For further product information, refer to the Patient Manual PN1067796-00 or contact EBI® Customer Care at 800-526-2579.
References:
- Hallie B. Murray and Brian A. Pethica. 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 Dec; 8:67-72. For patients with tibia, tibia/fibula or scaphoid nonunion fractures.
+ The original PEMF clinical study which led to PMA approval in 1979 yielded an overall functional success rate of 76% SS&ED.