Bioventus EXOGEN Guia Del Usuario página 4

EXOGEN Overview
Indications for Use
The EXOGEN Ultrasound Bone Healing System
is indicated for:
• The non-invasive treatment of established
non-unions excluding skull and vertebra
†
• The EXOGEN device has also been reported
as effective as an adjunctive non-invasive
treatment of established non-unions 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.
• Accelerating the time to a healed fracture for fresh,
closed, posteriorly displaced distal radius fractures
(fractures of the end of the large bone in your
forearm) and fresh, closed or Grade I open tibial
diaphysis fractures (fractures in the middle 80%
of the large bone in your lower leg) in skeletally
mature individuals when these fractures are
orthopaedically managed by closed reduction
and cast immobilization (adult individuals eighteen
years of age or older who have fractures, with or
without minor skin wounds, that are placed in a
cast for treatment).
A non-union is considered to be established when
†
the fracture site shows no visibly progressive signs
of healing.
1
EXOGEN Description
The EXOGEN Ultrasound Bone Healing System
provides non-invasive therapy for healing
non-unions and accelerating time to healing of
fresh fractures. EXOGEN is designed both for
use with conservatively-treated fresh fractures
and non-unions, or surgically-treated non-unions.
EXOGEN transmits a low-intensity ultrasound
signal to the fracture site through coupling gel,
with little or no sensation felt by the patient
during the treatment. Low-intensity pulsed
ultrasound has been shown in in-vitro and in-
vivo studies to stimulate cells to produce growth
factors and proteins that are important to bone
healing.
EXOGEN Device
Figure 1: EXOGEN Ultrasound Bone Healing System
The patient administers treatment at home
or at work, once daily, for 20 minutes, or as
prescribed by a physician. EXOGEN auto-
matically alerts the patient in case of improper
application or performance. The EXOGEN
Ultrasound Bone Healing System consists of
one EXOGEN device, a charger, a gel bottle
and strap. The EXOGEN device provides the
treatment control circuitry, the battery supply
and monitors the operation of the transducer
at the fracture site. The signal specifications
cannot be changed.
Everything you need to treat your fracture is
included in the EXOGEN Ultrasound Bone
Healing System. (See Figure 1). If one of the
items in Figure 1 is missing, please contact
Customer Service at 1-800-836-4080 to
receive a replacement.
Gel
Charger
Strap