EXOGENSNTM

1 Summary of Indications for Use: The EXOGEN 4000+^◊, or any other EXOGEN^◊ Bone Healing System, is indicated for the non-invasive treatment of established non-unions† excluding skull and vertebra.

* In addition, they are 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.

Contraindications: There are no known contraindications for the EXOGEN^◊ device.

Warnings and precautions pertaining to the treatment of either condition may be found at www.exogen.com or by calling 1-800-836-4080.

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

 
2 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 Jan;76(1):26–34.
 
3 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 Oct;51(4):693–703.