Indications for Use
EXOGEN is indicated for the non-invasive treatment of established nonunions, excluding skull and vertebra. It has been shown to accelerate the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization.
EXOGEN has no known contraindications.
The current EXOGEN product label includes treatment indications that have been approved for use by the FDA. FDA approval is based on reviews of extensive clinical data sponsored by Bioventus to support the effectiveness and safety of EXOGEN in these indications. “Unapproved use” refers to conditions for which a specific approved indication has not yet been granted by the FDA. For EXOGEN, many “unapproved uses” have not been adequately studied for effectiveness and safety by Bioventus to an extent that would result in FDA approval.
Fracture Treatment
Yes, the biological effect of the ultrasound beam goes around the entire fracture by shear waves.65
EXOGEN ultrasound waves can penetrate through skin and soft tissue for an effective penetration depth of ~10 inches (250 mm).65
Active, implantable devices such as cardiac pacemakers may be adversely affected by close exposure to the EXOGEN device. Patients or other people in close proximity during treatment should be evaluated by a cardiologist or physician before using the EXOGEN device.
Mark the fracture location on your patient. The EXOGEN transducer must be in direct contact with skin, so if your patient needs or currently has a cast, you’ll need to build in a transducer port or create a window. Our trained EXOGEN specialists will assist you with proper placement of the transducer port for casting and use with metals for nonunion fractures. For more information, download the EXOGEN Casting Application Techniques or contact Bioventus Customer Service at 1-800-836-4080.
EXOGEN Device & Coverage
The EXOGEN unit consists of the main operating unit and the attached cable with transducer head. Patients also receive an application strap, coupling gel, and battery charger.
Many insurers cover the EXOGEN device.13-16 For more information, contact your local EXOGEN representative or contact Bioventus Customer Service at 1-800-836-4080.
Use HCPCS code E0760 and include a description of the device: EXOGEN Ultrasound Bone Healing System by Bioventus.
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Summary of Indications for Use
The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established nonunions* excluding skull and vertebra. The EXOGEN device has also been reported as effective as an adjunctive non-invasive treatment of established nonunions in patients:
- With internal or external fracture fixation hardware present. EXOGEN cannot penetrate metal and therefore should not be applied directly over hardware.
- Undergoing treatment for infection at the fracture site. EXOGEN is not intended to treat the infection.
- Believed to have diminished bone quality. EXOGEN is not intended to treat diminished bone quality.
In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization.
There are no known contraindications for the EXOGEN device. Safety and effectiveness have not been established for individuals lacking skeletal maturity, pregnant or nursing women, patients with cardiac pacemakers, on fractures due to bone cancer, or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel.
*A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
Full prescribing information can be found in product labelling, at EXOGEN.com, or by calling Customer Service at 1-800-836-4080.
