BELOW ARE THE MOST COMMONLY ASKED QUESTIONS ABOUT EXOGEN.
FAQ - Physician CAE
The EXOGEN Performance Program guarantees that radiographic healing progression will be shown in stable, non-displaced, established nonunion,* delayed union or acute fracture with a fracture gap less than 10 millimeters (excluding vertebra and skull fractures). If the requirements of the program are met and no healing progression is shown, out-of-pocket payments paid to Bioventus 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.
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 Care at 1-855-771-0606.
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.
Yes, the actions of EXOGEN to treat nonunion† fractures are non-cavitating and nonthermal.44,45 Testing shows that it produces no untoward effects or migration of fixation.46 It is recommended to not place the transducer on top of fixation material, but to chose a different angle to reach the fracture, as metalwork will block the ultrasound wave.
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 call Bioventus Customer Care at 1-855-771-0606.
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 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 orthopedically 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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