Proven Technologies for Active Healing.
Explore the largest portfolio of clinically proven solutions engineered to enhance bone healing and improve patient outcomes.
NON-surgical DEVICES
Comfortable, At-Home Therapy Backed by Clinical Evidence
Biomet® SpinalPak®
Non-invasive Spine Fusion Stimulator System
The Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator is an FDA approved, non-invasive bone growth stimulation device designed as an adjunctive therapy to aid in the healing of spinal fusions.
Key Features:
The small, intuitive device encourages patients to treat compliantly on the go while improving their fusion outcomes
The lightweight, flexible, Soft-Touch® electrodes weigh less than an ounce, minimizing unwanted weight around the treatment site
The flexible placement of the Soft-Touch® electrodes optimizes precise stimulation, penetrating evenly across the targeted treatment area
The Soft-Touch® electrodes may be comfortably and discreetly worn under a brace
Backed by statistically significant pre-clinical, scientific research and clinical evidence which demonstrated improved clinical outcomes
Biomet® OrthoPak®
Non-invasive Bone Growth Stimulator System
The Biomet® OrthoPak® Non-invasive Bone Growth Stimulator is an FDA approved, non-invasive bone growth stimulation device designed as an adjunctive therapy to aid in the healing of established nonunions.
Key Features:
The small, intuitive device encourages patients to treat compliantly on the go while improving their healing outcomes
The lightweight, flexible, Soft-Touch® electrodes weigh less than an ounce, minimizing unwanted weight around the treatment site
The flexible placement of the Soft-Touch® electrodes optimizes precise stimulation, penetrating evenly across the targeted treatment area
The Soft-Touch® electrodes may be comfortably and discreetly worn under clothing or a brace
Backed by statistically significant pre-clinical, scientific research and clinical evidence which demonstrated improved clinical outcomes
Biomet® EBI®
Bone Healing System
The Biomet® EBI® Bone Healing System is an FDA approved, non-invasive bone growth stimulation device designed as an adjunctive therapy to aid in the healing of nonunion fractures, failed fusions, and congenital pseudarthrosis.
Key Features:
The only bone growth stimulator with three distinct indications, providing surgeons options to treat various conditions with one clinically proven, safe and effective nonsurgical device
The small, lightweight, easy-to-use device empowers patients to treat compliantly on the go while improving their healing outcomes
The 12 flexible, hand-crafted, therapeutic treatment coil options provide complete, 360-degree coverage around the treatment site
The therapeutic treatment coils may be comfortably and discreetly worn over clothing, bracing, or a cast
Backed by statistically significant pre-clinical, scientific research and clinical evidence which demonstrated improved clinical outcomes
SURGICAL DEVICES
Continuous, Around-the-Clock Stimulation
SpF®
Implantable Spinal Fusion Stimulators
The SpF® implantable stimulator is a class III, FDA approved, bone growth stimulation implant designed as an adjunctive therapy to aid in the healing of spinal fusions. It is a proven, safe and effective electrical bone growth stimulation therapy that has improved patient healing outcomes for over 35 years.
Key Features:
The first and only bone growth stimulation implant to support spinal fusion outcomes
The unique cathodes are placed precisely over the targeted treatment site offering controlled treatment to the area where patient’s need it most
The device provides constant, around-the-clock stimulation therapy, empowering surgeons to improve their patient’s healing outcomes with no concern for compliance
The innovative cathode design enables increased surface area for active bone growth stimulation at the targeted treatment site
The sterilely packed implant improves operational efficiencies; no special instrumentation required
EBI® OsteoGen™
Surgically Implanted Bone Growth Stimulators
The EBI® OsteoGen™ implantable stimulator is a class III, FDA approved, implantable bone growth stimulation device designed as an adjunctive therapy to aid in the healing of nonunion fractures. It is a proven, safe and effective bone growth stimulation therapy that has been improving patient outcomes for over 40 years.
Key Features:
The first and only long bone growth stimulation implant to support fracture nonunion healing outcomes
The unique cathodes are placed precisely over the targeted treatment site offering controlled treatment to the area where patient’s need it most
The device provides constant, around-the-clock stimulation therapy, empowering surgeons to improve their patient’s healing outcomes with no concern for compliance
The innovative cathode design enables increased surface area for active stimulation at the targeted treatment site
The sterilely packed implant improves operational efficiencies; no special instrumentation required
EBI Acquires Xstim
Description: Xstim Spine Fusion Stimulator passes a specific current between the electrodes in order to promote healing by inducing a therapeutic, low level electrical current at the fusion site. Federal law restricts this device to sale by or on the order of a physician. Prescription (Rx) only. This device is not intended for re-sale.
Indications for Use: The Xstim Spine Fusion Stimulator is a noninvasive bone growth stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. The device is for prescription use only, and intended for single patient use in adult patients only.
Contraindications: There are no known contraindications.
Warnings: Cardiac pacemakers or cardioverters may be adversely affected by Xstim Spine Fusion Stimulator. The concomitant use of Xstim Spine Fusion Stimulator and a pacemaker or cardioverter must be assessed on an individual basis, such as with an electrocardiogram, prior to use. The patient should be referred to a cardiologist for monitoring of pacemaker function while wearing the active stimulator device. If there are any observable adverse changes in the pacemaker rhythm or output, Xstim Spine Fusion Stimulator should not be used. The safety and effectiveness of Xstim Spine Fusion Stimulator in pregnant women have not been studied and the effects of Xstim Spine Fusion Stimulator on the mother or the developing fetus are unknown. A patient who is either pregnant or is intending to become pregnant should be referred to her doctor prior to treatment with Xstim Spine Fusion Stimulator.
Precautions: The safety and effectiveness of Xstim Spine Fusion Stimulator in individuals with the following conditions have not been studied, and therefore the safety and effectiveness of Xstim Spine Fusion Stimulator in these individuals are unknown: spondylitis, infection, Paget’s disease, cancer, diabetes mellitus, renal disease, osteoporosis, trauma of the lumbar spine. Apply the electrodes after the skin has been cleaned and dried. If erythema develops at the electrode sites, the electrodes should be relocated adjacent to the original sites. If the reaction does not resolve after 48 hours after relocating the electrodes, the patient should be instructed to consult with the physician. Do not submerge or expose Xstim Spine Fusion Stimulator to water. The patient must be instructed to remove Xstim Spine Fusion Stimulator during bathing, showering or swimming. Compliance with the treatment schedule, daily battery pack changes, and replacing the electrodes (1 to 7 days) as needed are essential for proper device function. This system should only be used with components and replacement parts supplied by Xstim Spine Fusion Stimulator. Other components, parts and accessories may not be compatible and may damage Xstim Spine Fusion Stimulator. If any component does not function properly, contact Customer Service at (844) 228-2067. No attempt should be made to modify or repair Xstim Spine Fusion Stimulator. Patients should be able to use Xstim Spine Fusion Stimulator in accordance with the instructions for use. If a patient cannot comply with these instructions for any reason, use of Xstim Spine Fusion Stimulator is not recommended.
