Bioventus EXOGEN - EXOGEN Overview; Indications for Use; EXOGEN Description

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EXOGEN Overview
Indications for Use
EXOGEN Ultrasound Bone Healing System
is indicated for the non-invasive treatment
of osseous defects (excluding vertebra and
skull) that includes:
• Treatment of delayed unions and
non-unions
†
• Accelerating the time to heal of fresh
fractures
• Treatment of stress fractures
• Accelerating repair following osteotomy
• Accelerating repair in bone transport
procedures
• Accelerating repair in distraction
osteogenesis procedures
• Treatment of joint fusion
†
A non-union is considered to be established
when the fracture site shows no visibly
progressive signs of healing.
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 can
be used on both fresh fractures and non-
unions - and both can be conservatively
or surgically treated. 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 ultra-
sound 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.
The patient administers treatment at home
or at work, once daily, for 20 minutes, or
as prescribed by a physician. EXOGEN
automatically 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 specications 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
1-855-771-0606 to receive a replacement.
Figure 1: EXOGEN Ultrasound Bone Healing System
EXOGEN Device
Gel
Charger
Strap
EXOGEN OVERVIEW