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All revisions of the Instructions for Use can be made available upon request. Contact [email protected] or call 0800 05 16 384 to request an electronic copy.
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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 https://www.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.
