For answers to specific questions about your fracture, please consult your treating physician. Only your doctor can provide medical advice.
A: Yes, EXOGEN has been shown to be safe in clinical studies that support its indicated uses. It has also been approved by the FDA, which regulates drugs and medical devices in the US.
A: EXOGEN has been clinically demonstrated to accelerate healing of indicated* fresh fractures 2,12 and to help heal non-union* fractures.1,16 For more information on your fracture and expected healing time, talk with your doctor.
A: No, there are no known contraindications for the use of the EXOGEN device. For more information, see the EXOGEN package insert.
A: EXOGEN is approved for use in patients with fully matured skeletons and has not been studied in patients lacking skeletal maturity. Your doctor will determine when it is medically appropriate to use EXOGEN.
A: These sections highlight situations in which the safety and effectiveness of EXOGEN has not been established. These situations are often specific patient circumstances involving certain types of medication or medical problems other than fractures. If you have questions about your situation or treatment, talk with your doctor.
A: The operation of active, implantable devices such as cardiac pacemakers may be adversely affected by close exposure to the EXOGEN device. If you have a pacemaker, talk with your doctor or cardiologist about using the EXOGEN system. He or she is the most qualified person to direct your EXOGEN treatment plan.
A: Smith & Nephew works with many private and public healthcare payers. Once we receive your prescription and insurance information, we will verify coverage for you. You can also contact our patient advocacy helpline at (800) 847-2381 for more information.
A: In clinical studies, patients used EXOGEN for one 20-minute treatment each day. We have not studied the safety and effectiveness of using the device more often. Consult your doctor for specific guidelines on use.
A: No, the EXOGEN transducer requires direct contact with skin and the use of a coupling gel (which is provided). Ultrasound waves cannot travel through air or clothing.
A: The EXOGEN device uses a non-replaceable lithium battery that will power at least 150 20-minute treatments and most device batteries last much longer. If your device requires battery service before your fracture is healed, please contact our clinical therapies service center at (800) 836-4080.
A: Humans can’t sense ultrasound vibrations, so you’ll never feel a treatment. If your EXOGEN device display shows a timer countdown, the unit is working. If at any time the device stops functioning properly, the attention signal (an exclamation point inside a triangle) will appear on the screen. If this happens, please contact our clinical therapies service center at (800) 836-4080.
A: EXOGEN is a regulated device that should only be used by the person for whom it is prescribed. The device is yours to keep once your treatment is complete. You may also send the device back to Smith & Nephew for proper disposal. For shipping information, please contact our clinical therapies service center at (800) 836-4080.
A: No, patients cannot make adjustments to the EXOGEN unit.
A: Mineral oil can be used in place of the coupling gel that comes with the EXOGEN device. Petroleum jelly, however, is not an acceptable substitute. You may also request more coupling gel by calling our customer service center at (800) 836-4080.
A: Please contact an EXOGEN patient account representative at (800) 580-0900.
A: EXOGEN CONNECTS is an optional treatment reminder program that can help you use your device consistently, which will give you the best possible results. The program is free to join and you can choose to receive reminders via email, text messages or phone. To learn more, visit exogenconnects.com.
Call us at (800) 836-4080 or contact us on the web today.
Want to know more? Download the EXOGEN patient brochure.
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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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