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. There are no known contraindications for the EXOGEN device. 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. The EXOGEN device has also been reported as effective as an adjunctive non-invasive treatment of established nonunions in patients: The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established nonunions* excluding skull and vertebra. *The clinical relevance of in vivo findings is unknown †A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing Some patients may be sensitive to the ultrasound gel.
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. 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 orthopaedically managed by closed reduction and cast immobilization. EXOGEN is not intended to treat diminished bone quality. Believed to have diminished bone quality.EXOGEN is not intended to treat the infection. Undergoing treatment for infection at the fracture site.EXOGEN cannot penetrate metal and therefore should not be applied directly over hardware. With internal or external fracture fixation hardware present.The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established nonunions † excluding skull and vertebra.
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