BELOW ARE THE MOST COMMONLY ASKED QUESTIONS ABOUT THE EXOGEN DEVICE.
FAQ - Physician US
The EXOGEN Performance Program guarantees that radiographic healing progression will be shown in nonunion fractures. If the requirements of the program are met and no healing progression is shown, out-of-pocket costs will be refunded to the patient.
EXOGEN CONNECTS is a free smartphone app designed to help patients use their device consistently and as prescribed. The app sends automated treatment reminders and provides helpful healing information to encourage daily use.
The current EXOGEN product label includes treatment indications that have been approved for use by the FDA. FDA approval is based on reviews of extensive clinical data sponsored by Bioventus to support the effectiveness and safety of EXOGEN in these indications. “Unapproved use” refers to conditions for which a specific approved indication has not yet been granted by the FDA. For EXOGEN, many “unapproved uses” have not been adequately studied for effectiveness and safety by Bioventus to an extent that would result in FDA approval.
Labeling for a device is subject to requirements of a country’s or region’s governing regulatory authority. As such, labels may vary in indications and content depending on a regulatory authority’s particular requirements.
Many insurers cover the EXOGEN device. For more information, contact your local EXOGEN representative or contact Bioventus Customer Service at 1-800-836-4080.
Use HCPCS code E0760 and include a description of the device: EXOGEN Ultrasound Bone Healing System by Bioventus.
Active, implantable devices like cardiac pacemakers may be adversely affected by close exposure to the EXOGEN device. Patients or other people in close proximity during treatment should be evaluated by a cardiologist or physician before using the EXOGEN device.
EXOGEN has no known contraindications.
The EXOGEN transducer must be in direct contact with skin, so if your patient needs or currently has a cast, you’ll need to build in a transducer port or create a window. Our trained EXOGEN specialists will assist you with proper placement of the transducer port for casting and use with metals for nonunion fractures. For more information, download the EXOGEN Casting Application Techniques or contact Bioventus Customer Service at 1-800-836-4080.
The EXOGEN unit consists of the main operating unit and the attached cable with transducer head. Patients also receive an application strap, coupling gel and battery charger.
Tibia fractures up to 6.35 cm in length were healed in clinical trials using the EXOGEN system.2 The biological effect of the ultrasound beam spreads around the entire fracture by stimulating cells facing the transducer, by penetrating the bone to stimulate cells on the bone’s far side and by transmitting longitudinal and shear waves around the bone.41
In a clinical evaluation, EXOGEN had a 92% success rate in treating nonunions of the femur,42 suggesting that EXOGEN is an excellent choice for patients with deep fractures.
The EXOGEN ultrasound beam expands to reach a width almost 2.5 times the size of the transducer. At its widest, the effective diameter of the ultrasound beam is more than 5 cm, and the therapeutic span is more than 3.4 cm—even after passing through 20 cm of soft tissue.39 EXOGEN ultrasound waves can penetrate through skin and soft tissue to reach bone up to 26.5 cm deep.43
EXOGEN is indicated for the non-invasive treatment of established nonunions, excluding skull and vertebra. It has been shown to accelerate 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.
The most common type of bone healing has four main stages. A broken bone starts to heal immediately after the injury, during the acute inflammatory phase. Next, your bone begins to develop new tissue at the ends of the fractured bone, called a soft callus. Over a period of the next two to three weeks, the soft callus is replaced with harder tissue, which is called a hard callus. The hard callus adds structure and strength to the newly formed bone tissue. Finally, your broken bone is remodeled to a fully functioning bone. Keep in mind that even after your broken bone has fully healed, the outer bone surface may be slightly swollen for a period of time.
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