EXOGEN*
Bone Healing System
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The EXOGEN◊ 4000+, or any other EXOGEN◊ Bone Healing System, is indicated for the non-invasive treatment of established nonunions† 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.
†A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
There are no known contraindications to the use of this device.
Warnings:
The safety and effectiveness of the use of this device has not been established in nonunions for the following:
nonunions of the vertebra and the skull.
individuals lacking skeletal maturity
Precautions:
The safety and effectiveness of the use of this device in pregnant or nursing women has not been established.
Careful consideration of the use of this device must be decided on an individual basis in the presence of malaligned nonunion since the device will not correct or alter displacement, angulation or other malalignment.
With active, implantable devices, such as cardiac pacemakers, operation may be adversely affected by close exposure to the EXOGEN◊ device; therefore, evaluation during EXOGEN◊ treatment by the attending cardiologist or physician is recommended.
Cell phones may cause interference and patients should avoid cell phone use during treatments.
Patients in the clinical studies were instructed to apply the device for one treatment period of 20 minutes each day. The safety and effectiveness of the EXOGEN◊ device when used for more than one daily 20-minute treatment period is unknown.
The age ranges of the patients in the PMA nonunion studies were 17–86. The effect of EXOGEN◊ therapy on patients outside this age range is unknown.
Complications:
No device-related adverse reactions or medical complications related to the use of this device were reported during the clinical studies. Two patients in a postmarket registry reported mild skin irritation caused by skin sensitivity to the coupling gel. Both were resolved by a change of coupling medium to mineral oil or glycerin.
Warnings:
The safety and effectiveness of the use of this device has not been established for the following:
- Fracture locations other than the distal radius or tibial diaphysis.
- Fractures with post-reduction displacements of more than 50%.
- Fractures that are open Grade II or III or that require surgical intervention or with internal or external fixation or that are not sufficiently stable for closed reduction and cast immobilization.
- Individuals lacking skeletal maturity or who are pregnant/nursing women.
- Pathological fractures due to bone pathology or malignancy.
- Individuals with thrombophlebitis, vascular insufficiency, abnormal skin sensitivity, sensory paralysis, alcoholism and/or nutritional deficiency.
- Individuals receiving steroid, anti-coagulant, prescription nonsteroidal anti-inflammatory, calcium channel blocker and/or diphosphonate therapy. Individuals using these therapies were excluded from the studies because of the possible effects of these therapies on bone metabolism.
Precautions:
- Animal studies conducted to date do not suggest any long term adverse effects from the use of this device. Clinical studies conducted for the EXOGEN◊ PMA with long term patient follow up for up to 78 months do not suggest any long term adverse side effects from the use of this device. However, possible longer-term adverse effects in humans are unknown.
- This device will not correct or alter post-reduction aspects of a fracture such as displacement, angulation or other malalignment.
- The age ranges of the patients in the fresh fracture PMA study were 17–67 years of age (54% were 31 years of age or older) in the tibia study and 20–78 (74% were 50 years of age or older) in the distal radius (Colles’) study. The effect of EXOGEN◊ therapy on patients outside this age range is unknown.
- Operation of active, implantable devices, such as cardiac pacemakers, may be adversely affected by close exposure to the EXOGEN◊ device. The physician should advise the patient or other person in close proximity during treatment to be evaluated by the attending cardiologist or physician before starting treatment with the EXOGEN◊ device.
- Cell phones may cause interference and patients should avoid cell phone use during treatments.
- The clinical studies for the EXOGEN◊ PMA required only one daily treatment period of 20 minutes. Although the EXOGEN◊ device can be used more than once per day, the effects of multiple daily treatments are unknown; therefore, it is important that you prescribe only one daily 20-minute treatment period.
Complications:
No device-related adverse reactions or medical complications related to the use of this device were reported during the tibia or distal radius studies. In the distal radius study, one patient complained of pain during treatment but this resolved by the next follow up visit and one patient, complaining of pain, withdrew from the study.
