A: EXOGEN is the only system approved by the FDA for accelerating indicated* fresh fracture healing and the only device that uses low-intensity, pulsed ultrasound (LIPUS) signals — a unique technology that stimulates an orthobiologic response at the cellular level.10 EXOGEN is also recognized by the Centers for Medicare & Medicaid Services as a unique technology and has been issued a unique HCPCS code (E0760) unlike other bone stimulation devices, which share a single code.
A: While most bones do heal with immobilization, up to 10% become non-unions.*23 Treatment options for non-unions* are limited and, in the absence of external bone healing technology, may result in expensive surgical procedures, at an average cost of $45,000 per case.25 EXOGEN has a demonstrated overall 86%1 heal rate for non-union* fractures and may help reduce the necessity of non-union* surgeries — a significant savings. EXOGEN may also help speed the healing of indicated* fresh fractures. This is especially important in helping workers return to their jobs.
A: EXOGEN may reduce costs associated with surgery, outpatient care and other device costs. An analysis of treatment costs associated with non-union* tibia fractures showed that EXOGEN may save as much as $15,000 per case.24
A: EXOGEN treatments are only 20 minutes per day — the shortest treatment time of any available bone healing stimulation device. The short treatment time allows patients to receive their treatments while enjoying a meal or watching TV, which minimizes hassle and may encourage compliance. In addition, Smith & Nephew offers the EXOGEN CONNECTS patient adherence program, which provides users of EXOGEN with free treatment reminders.
A: Since the EXOGEN device is designed and FDA-approved for single patient application, it can’t be used among different patients. The device must be prescribed by a physician for the patient who will be using the device for treatment.
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*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. Full prescribing information can be found in product labeling, at www.exogen.com or by contacting customer service at 1-800-836-4080.
†A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.
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