![]() Contact or call 0800 05 16 384 to request an electronic copy. *A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.Īll revisions of the Instructions for Use can be made available upon request. 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.įull prescribing information can be found in product labeling, at, or by calling Bioventus Customer Service. †A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.įull prescribing information can be found in product labelling, at, or by calling Customer Service at 1-80.ĮXOGEN 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. 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. 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. ![]() EXOGEN is not intended to treat diminished bone quality. Just 20 minutes a day of safe, painless treatment can significantly. The Exogen device was found to be no more effective at healing fractures than a. Believed to have diminished bone quality. EXOGEN makes it easy to do more than simply wait to heal. Bioventus said the funding was pulled to prevent inconvenience to patients and to reduce their exposure to X-rays.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 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. EXOGEN Turns Your Downtime into Healing Time. ![]()
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