What is a bone stimulator?

Bone stimulators are devices that promote bone healing via energy fields directed at the site of indicated acute fractures and nonunions.48

Human bone is living tissue, and thus has the ability to heal itself when it is injured or broken. There are a number of complex molecular reactions that occur during the bone healing process.48

Bone stimulators promote bone healing by stimulating this aspect of the body’s natural bone healing process.48 The energy from these devices enhance the bone healing process by triggering the cascade of complex molecular reactions that occur during the bone healing process.48

There are several different types of technologies that are used by bone stimulators to generate the energy they apply to a broken bone. These different technologies include direct current, capacitive coupling, pulsed electromagnetic fields, and low-intensity pulsed ultrasound.49 The most commonly used bone stimulators are electrical stimulators and ultrasound stimulators.49

Bone stimulators come in different shapes and sizes. A small battery pack is the source of energy for most bone stimulators. Bone stimulators are usually attached at the site of the fracture and worn for a specific period of time each day, varying from minutes to hours.48

Nonunion fractures
Bone stimulators are used to facilitate healing of acute or fresh fractures, as well as nonunion fractures.48 These types of fractures may be the result of a complication, such as an infection at the site of the injury or impaired blood flow to the site of the bone tissue. People who have diabetes or smoke cigarettes may have impaired blood flow to the broken bone.8,10,45 Other causes of a nonunion fracture may be improper alignment of the broken ends of the bone or inadequate immobilization during the healing process.45

Efficacy of Ultrasound Bone Stimulation
Preclinical research in laboratory animals has found that the low-intensity pulsed ultrasound device enhances a number of molecular reactions involved in bone healing. *37,38,50,51 Clinical research in patients with a bone fracture has provided further support for the efficacy of ultrasound bone stimulation; the time to heal certain fresh fractures was accelerated by 38%, and 86% of established nonunion fractures were healed with ultrasound bone stimulation.1-3

EXOGEN Ultrasound Bone Healing System
EXOGEN provides pulsed ultrasound bone stimulation. This device delivers safe, low-intensity ultrasound waves that trigger the natural bone healing process. Daily treatment with EXOGEN facilitates your natural bone healing by three actions:

1. Stimulation*36
EXOGEN sends ultrasound waves through the skin, creating movement that stimulates your body’s cells.

2. Activation*37
EXOGEN ultrasound activates cells in your body.

3. Upregulation*38
Upregulation is increased by EXOGEN ultrasound waves that increase factors that help jump-start your body to heal your fracture.

Read more about how EXOGEN´s bone stimulator works here, and find out if it’s right for you!

*The clinical significance of these findings is unknown.
Please see full prescribing information at www.exogen.com or by calling Bioventus Customer Service.

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.