FAQs

Q: What is EXOGEN approved for in the US?

A: The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established non-unions^† 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. (^†A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.)  

Q: How effectively does EXOGEN penetrate soft tissue?

A: 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.¹⁰ EXOGEN ultrasound waves can penetrate through skin and soft tissue to reach bone up to 26.5 cm deep.¹⁷

Q: Is EXOGEN treatment effective with deep fractures such as in the femur?

A: In clinical evaluation, EXOGEN had a 92% success rate in treating non-unions* of the femur,¹⁸ suggesting that EXOGEN is an excellent choice for patients with deep fractures.

Q: Is EXOGEN able to treat the entire fracture?

A: 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.¹⁹

Q: What does the EXOGEN unit include?

A: The EXOGEN unit consists of the main operating unit (MOU) and the attached cable with transducer head. Patients also receive an application strap and coupling gel.

Q: What do I need to do to prepare my patient for EXOGEN treatments?

A: 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 non-union* fractures. For more information, contact a rep today or see Prescribing EXOGEN.

Q: Can EXOGEN be used safely with metal fixation of non-union* fractures?

A: Yes. EXOGEN is non-cavitating and non-thermal for non-union* fractures.^20,21 Testing shows that it produces no untoward effects or migration of fixation.²²

Q: Does EXOGEN have any contraindications?

A: No. There are no known contraindications.

Q: Can patients with cardiac pacemakers or other active, implantable devices use EXOGEN?

A: 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.

Q: How do I code a fracture when prescribing the EXOGEN device?

A: For billing codes and more, download the EXOGEN Coding and Billing Guide.

Q: Which HCPCS code should I use to ensure my patient receives the EXOGEN system?

A: Use HCPCS code E0760, and include a description of the device: EXOGEN Ultrasound Bone Healing System by Smith & Nephew. For more information, download the EXOGEN Coding and Billing Guide.

Q: Will insurers cover EXOGEN?

A: Yes, many insurers cover the EXOGEN device. For more information, contact your local EXOGEN representative. If you don’t know who your representative is, request a call.

Q: Why are there differences in the labels for EXOGEN in the US and countries outside the US?

A: 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. 

Q: What is the difference between "approved use" and "unapproved use?"

A: 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 Smith & Nephew 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 Smith & Nephew to an extent that would result in FDA approval.

Q: How can EXOGEN CONNECTS help my patients heal?

A: EXOGEN CONNECTS is an optional treatment reminder program that can help patients follow your treatment plan and use their device consistently. The program is free to join and patients can choose to receive reminders via email, text messages or phone. To learn more, visit exogenconnects.com.