| Use in Burn and Reconstructive
Surgery |
|
In 1996, the US Food and Drug Administration
(FDA) approved the use of INTEGRA® Dermal Regeneration
Template for the treatment of life threatening burn injuries.
Since then, nearly 10,000 patients have been successfully
treated using the INTEGRA® Dermal Regeneration
Template.
In 2002, the FDA approved the use of INTEGRA
®
Dermal Regeneration Template to include the reconstruction
of scar contractures. This new indication provides relief
for thousands of individuals living with disabling scarring
from prior burns.
In 2014, the FDA approved the use of
Integra® Meshed Dermal Regeneration Template
for the treatment of life threatening burn injuries and
the reconstruction of scar contractures.
Indications for Use - U.S.A.
Burns
INTEGRA® Template is indicated for the post-excisional treatment
of life threatening full-thickness or deep partial-thickness
thermal injuries where sufficient autograft is not available
at the time of excision or not desirable due to the physiological
condition of the patient.
Reconstruction
INTEGRA® Template is indicated
for the repair of scar contractures when other therapies
have failed, or when donor sites for repair are not sufficient
or desirable due to the physiological condition of the
patient.
