EXOGEN Performance Programme Brochure
Detailed information on the EXOGEN Performance Programme: guidelines and requirements.
EXOGEN Quick Instruction Guide
The guide provides step-by-step instructions to quickly start using your EXOGEN device.
Design Evolution of EXOGEN Enhances Patient Compliance
N. Pounder, PhD, Sr. Director, Program and Alliance Management - Bioventus LLC
Acute Fractures
- Acceleration of tibia and distal radius fracture healing in patients who smoke.
- Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound.
- Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study.
Nonunion Fractures
- Indications and results for for the Exogen™ ultrasound system in the management of nonunion: a 59-case pilot study.
- Low-intensity pulsed ultrasound in the treatment of nonunions.
- Low-intensity pulsed ultrasound: effects on nonunions.
- Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial.
- The evaluation of the healing rate of subtalar arthrodeses, part 2: the effect of low-intensity ultrasound stimulation.
- Compound high-energy limb fractures with delayed union: our experience with adjuvant ultrasound stimulation (exogen).
- Failure of surgery for scaphoid non-union is associated with smoking.
- Treatment of chronic (>1 year) fracture nonunion: heal rate in a cohort of 767 patients treated with low-intensity pulsed ultrasound (LIPUS).
Other
- Mode & mechanism of low intensity pulsed ultrasound (LIPUS) in fracture repair.
- Prolonged endochondral bone healing in senescence is shortened by low-intensity pulsed ultrasound in a manner dependent on COX-2.
- Sources of information influencing decision-making in orthopaedic surgery – an international online survey of 1147 orthopaedic surgeons.
- Design evolution enhances patient compliance for low-intensity pulsed ultrasound device usage.
The EXOGEN Performance Program is a Bioventus program that refunds the payment for EXOGEN if progression of healing (progression to bony union) is not shown per criteria below. The program is also designed to help reinforce patients’ adherence with the prescribed treatment.
Criteria
Buyers of EXOGEN participating in the program are eligible when the device has been prescribed by a qualified physician to treat a stable, well-aligned fracture with a fracture gap less than 10 millimeters (excluding vertebra and skull fractures). Patients must treat their fracture with EXOGEN per product instructions, for a minimum of 120 consecutive days and achieve a 90% minimum level of adherence.
Evaluation
To be eligible, your prescribing physician must determine that your bone has not healed, or progressed to a bony union after 120 consecutive days or more of EXOGEN treatment. This evaluation must be based on X-rays taken prior to and after the patient’s treatment with EXOGEN.
The EXOGEN device contains an internal patient usage monitor that records the date, time and duration of each treatment session must be returned with the claim. This monitor will be used by Bioventus to confirm that at least 90% treatment adherence is met.
Exclusions
- Fracture types:
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- Unstable
- Malaligned fracture
- Greater than 10 millimeters fracture gap
- Vertebra and skull
- Pathological
-
- Treatment of multiple fractures locations (the guarantee is only valid to treat a defined fracture)
- Modified and/or altered devices
- Alternative interventions occurred during the 120-day treatment period
- EXOGEN devices that were not purchased and received directly from Bioventus
- Customers who did not register to the EXOGEN Performance Program within the first 30 days of the initial treatment
- Patient who was not prescribed treatment with EXOGEN
- Other costs associated with the purchase (only the cost of the EXOGEN device will be refunded)
- Valid only in the United Kingdom and Ireland
You may contact Bioventus Customer Care for Assistance.
Claims must be received by Bioventus within one year of the fist EXOGEN treatment date.
Bioventus reserves the right to amend or cancel the program at any time.
- The EXOGEN Post-Market Data App contains real-world bone healing statistics, which can be used to benchmark your specific patients.
- It’s our free smartphone app that automatically tells you the heal rate associated with common fractures, factoring in patient risk factors and other relevant clinical considerations.
- Let the EXOGEN Post-Market Data App help you find the next appropriate patient.
Download the EXOGEN Post-Market Data App
Summary of Indications for Use
The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established nonunions* excluding skull and vertebra. The EXOGEN device has also been reported as effective as an adjunctive non-invasive treatment of established nonunions in patients:
- With internal or external fracture fixation hardware present. EXOGEN cannot penetrate metal and therefore should not be applied directly over hardware.
- Undergoing treatment for infection at the fracture site. EXOGEN is not intended to treat the infection.
- Believed to have diminished bone quality. EXOGEN is not intended to treat diminished bone quality.
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 orthopedically managed by closed reduction and cast immobilization.
There are no known contraindications for the EXOGEN device. Safety and effectiveness have 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.
*A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
Full prescribing information can be found in product labelling, at EXOGEN.com, or by calling Customer Service at 1-800-836-4080.
