athomeexperience - EXOGEN Ultrasound Bone Healing System

Patient
Physician

Home
- Patient
- Physician
Find an EXOGEN Rep
About EXOGEN
Patient Case Studies
Physician Resources
- Brochures and Guides
- Videos
Fracture Locator
FAQ
Contact Us

References
Contact Us
References
Contact
Privacy Policy
Privacy Policy
Privacy Practices
Privacy Practices
Terms of Use
Terms of Use

us

Summary of Indications for Use

The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established nonunions^* excluding skull and vertebra. The EXOGEN device has also been reported as effective as an adjunctive non-invasive treatment of established nonunions in patients:

With internal or external fracture fixation hardware present. EXOGEN cannot penetrate metal and therefore should not be applied directly over hardware.
Undergoing treatment for infection at the fracture site. EXOGEN is not intended to treat the infection.
Believed to have diminished bone quality. EXOGEN is not intended to treat diminished bone quality.

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.

There are no known contraindications for the EXOGEN device. 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. Some patients may be sensitive to the ultrasound gel.

^*A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

Full prescribing information can be found in product labelling, at EXOGEN.com, or by calling customer service at 1-800-836-4080.