EXOGEN Treatment Pathway

EXOGEN treatment pathway resource for physicians.

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EXOGEN Performance Program

Evaluation Form

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EXOGEN Performance Program

Registration form.

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EXOGEN Performance Program

Detailed information on the EXOGEN Performance Program; guidelines and requirements.

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EXOGEN Quick Instruction Guide

The guide provides step-by-step instructions to quickly start using your EXOGEN device.

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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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About EXOGEN

Overview of EXOGEN's Unique Benefits

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EXOGEN Mechanism of Action

Scientific explanation of EXOGEN's unique mechanism of action

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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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EXOGEN and Fracture Healing in Uncertain Times

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

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EXOGEN User Guide

Detailed information on using the EXOGEN system

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EXOGEN Casting Application Techniques

Instruction for building a transducer port into a new cast or creating a window in an existing cast

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EXOGEN Mechanism of Action Brochure

Scientific explanation of EXOGEN’s unique mechanism of action

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EXOGEN Introduction Brochure

Overview of the device and how it works.

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Acute Fractures
Nonunion Fractures

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:
      • 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

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Summary of Indications for Use

EXOGEN is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) that includes the treatment of delayed unions, nonunions,* stress fractures and joint fusion. EXOGEN is also indicated for the acceleration of fresh fracture heal time, repair following osteotomy, repair in bone transport procedures and repair in distraction osteogenesis procedures.

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.

Full prescribing information can be found in product labeling, at https://www.exogen.com/, or by calling Bioventus Customer Service.

*A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.