EXOGEN Ultrasound Bone Healing System | Mechanism of Action Video

EXOGEN Mechanism of Action

Scientific explanation of EXOGEN's unique mechanism of action

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Casting instructions for all installations

View the About EXOGEN video for an overview of the EXOGEN device.

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EXOGEN and Fracture Healing in Uncertain Times

Dr Zura, Orthopaedic Surgeon LSU – LSU Health Sciences Center New Orleans

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EXOGEN Accelerates Healing of Fractures in Smokers

Dr Zura, Orthopaedic Surgeon LSU – LSU Health Sciences Center New Orleans

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About EXOGEN

Overview of EXOGEN's Unique Benefits

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Certificate of Medical Necessity

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EXOGEN Performance Program Evaluation form

Evaluation Form

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EXOGEN Performance Program

Evaluation Form

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Design Evolution of EXOGEN Enhances Patient Compliance

N. Pounder, PhD, Sr. Director, Program and Alliance Management - Bioventus LLC

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EXOGEN User Guide

Detailed information on using the EXOGEN system

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Acute Fractures
Nonunion Fractures

The EXOGEN Performance Program is a Bioventus program that refunds patients their out-of-pocket payment for EXOGEN if progression of healing is not shown per criteria below. It is also designed to help reinforce patients’ adherence to the prescribed treatment.

Criteria

All patients who have purchased an EXOGEN designed for the treatment of a fracture, which was prescribed by a qualified physician to treat a stable, non-displaced, established nonunion,* delayed union or acute fracture with a fracture gap less than 10 millimeters (excluding vertebra and skull fractures) are eligible. All patients will automatically be enrolled in the program.

Patients must treat their fracture with EXOGEN per product instructions, for a minimum of 120 days and achieve a minimum adherence of at least 90%.

Evaluation

To be eligible, your prescribing physician must determine that your bone has not healed, or progressed to a bony union. The prescribing physician must provide two X-rays of your affected bone, one prior to using EXOGEN, and another taken after 120 days or more of EXOGEN treatment that shows a lack of bony union.

The EXOGEN device contains an internal patient usage monitor that records the date, time and duration of each treatment session. This monitor will be used by Bioventus to confirm that at least 90% treatment adherence is met.

Exclusions

  • Fracture types:
    • Unstable
    • Displaced
    • Greater than 10-millimeter fracture gap
    • Vertebra and skull
    • Pathological
  • Modified or altered devices
  • Patient treated with EXOGEN 4000+ model
  • The EXOGEN Performance Program is void if alternative interventions occur during the 120-day treatment period. If alternative intervention is needed, a new 120-day treatment period begins
  • EXOGEN must be purchased and received by the patient directly from Bioventus
  • The EXOGEN Performance Program applies only to patients for whom the device was prescribed
  • Any other costs associated with the purchase – only the patient’s out-of-pocket payment to Bioventus will be refunded

You may contact Bioventus Customer Care for assistance. All claims must be accompanied by the following:

  • Prescribing physician’s assessment: completion of the EXOGEN Performance Program evaluation form
  • Letter from the patient requesting a refund (including name, address and payment method)
  • Prescribed EXOGEN device returned to Bioventus

Claims must be received by Bioventus within one year of first EXOGEN treatment date.

Bioventus reserves the right to amend or cancel the program at any time.

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  • 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

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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.