Indications for Use
EXOGEN is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) that includes the treatment of delayed unions, nonunions,* stress fractures and joint fusion. EXOGEN is also indicated for the acceleration of fresh fracture heal time, repair following osteotomy, repair in bone transport procedures and repair in distraction osteogenesis procedures.
EXOGEN has no known contraindications.
Fracture Treatment
Yes, the biological effect of the ultrasound beam goes around the entire fracture by shear waves.61
EXOGEN ultrasound waves can penetrate through skin and soft tissue for an effective penetration depth of ~10 inches (254 mm).61
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.
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.
Some insurers cover the EXOGEN device. For more information, contact your local EXOGEN representative or contact Bioventus Customer Service.
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Summary of Indications for Use
EXOGEN is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) that includes the treatment of delayed unions, nonunions,* stress fractures and joint fusion. EXOGEN is also indicated for the acceleration of fresh fracture heal time, repair following osteotomy, repair in bone transport procedures and repair in distraction osteogenesis procedures.
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.
Full prescribing information can be found in product labeling, at EXOGEN.com, or by calling Bioventus Customer Service.
*A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
