EXOGEN is a device from Smith and Nephew that safely and painlessly speeds up natural bone healing using low intensity pulsed ultrasound.

Indications for use in the United States:
The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established non-unions† excluding skull and vertebra. 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.

† A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.

There are no known contraindications for the EXOGEN device. Safety and effectiveness has 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.

In addition EXOGEN has been approved in the European Union, Australia, New Zealand and Canada for the non-invasive treatment of osseous defects (excluding skull and vertebra) that includes:

- Treatment of delayed union and non-unions.
- Accelerating the time to heal fresh fractures.
- Treatment of stress fractures.
- Accelerating repair following osteotomy.
- Accelerating repair in bone transport procedures.
- Accelerating repair in distraction osteogenesis procedures.
- Treatment of joint fusion.

Full prescribing information can be found in product labeling, at www.exogen-intl.com, or by contacting customer service at 1-800-836-4080.

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