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Prescribing Information

EXOGEN -Faster Healing* for Fractured Bones

Using safe, painless ultrasound waves to activate cells near the site of the break, the EXOGEN Ultrasound Bone Healing System stimulates the body’s natural healing process1, helping fractured bones mend. When treating fractures, EXOGEN may be a cost-effective alternative to more invasive options.

EXOGEN has been demonstrated to heal 86% of stubborn-to-heal non-union bone fractures2.  Fresh Fractures can take weeks to heal, postponing when patients can return to their everyday lives. Clinical studies have demonstrated that it speeds the healing of an indicated* broken tibia or radius by 38% 3,4.

For more information including full prescribing information and clinical research, visit the EXOGEN website.

  1. Azuma Y, Ito M, Harada Y, Takagi H, Ohta T, Jingushi S. Low-intensity pulsed ultrasound accelerates rat femoral fracture healing by acting on the various cellular reactions in the fracture callus. J Bone Miner Res. 2001;16(4):671-680.
  2. Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH. Low-intensity pulsed ultrasound in the treatment of nonunions. J Trauma. 2001;51(4):693-703.
  3. Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surg Am. 1994;76(1):26-34.
  4. Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 1997;79(7):961-73.

*EXOGEN Summary of Indications for Use: 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.

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. Visit www.exogen.com for full prescribing information or to contact customer service.

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

BITS, Bioness, L300 Go, H200 Wireless, Vector Gait and Safety System are registered trademarks of Bioness, Inc. Bioventus and EXOGEN are registered trademarks of Bioventus.