| Frequently Asked Questions |
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If you would like immediate assistance with a question,
please contact one of our technical representatives
at 1-877-444-1122 or you may contact your local Plastic
and Reconstructive
Sales Specialist.
What is INTEGRA™ Flowable Wound Matrix?
What is INTEGRA™ Flowable Wound Matrix?
INTEGRA™ Flowable Wound Matrix is an
advanced wound care device comprised of a porous matrix
of cross-linked bovine tendon collagen and glycosaminoglycan.
The collagen-glycosaminoglycan biodegradable matrix provides
a scaffold for cellular matrix and capillary growth.
Is the INTEGRA™
Flowable Wound Matrix an FDA cleared product?
The INTEGRA™ Flowable Wound Matrix
received 510k clearance from the Food and Drug Administration
(FDA) in October 2007. To view the 510k clearance letter,
please
click here.
What is INTEGRA™ Flowable Wound Matrix indicated for?
INTEGRA™ Flowable Wound Matrix
is indicated for the management of wounds including:
partial and full-thickness wounds, pressure ulcers, venous
ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined
wounds, surgical wounds (donor sites/grafts, post-Moh's
surgery, post-laser surgery, podiatric, wound dehiscence),
trauma wounds (abrasions, lacerations, second-degree burns,
and skin tears) and draining wounds. The device is intended
for one-time use.
What are the key benefits of INTEGRA™ Flowable Wound Matrix?
- Biological alternative for deep, tunneling wounds
- Highly conformable for various
anatomical sites
- Room temperature storage
- Long shelf life
- Patients can begin rehabilitation with INTEGRA™
Flowable Wound Matrix in place
- Allows complete coverage in deep
creviced wounds in a minimally invasive manner
How does the INTEGRA™ Flowable Wound Matrix work?
INTEGRA™ Flowable Wound Matrix is placed
on a surgically debrided or excised wound and provides the
needed framework for the blood vessels and dermal skin cells
to rebuild the damaged site.
Who makes INTEGRA™ Flowable Wound Matrix?
INTEGRA™ Flowable Wound Matrix is manufactured
and distributed by Integra LifeSciences Corporation of Plainsboro,
New Jersey.
Are there any special storage conditions
for INTEGRA™ Flowable Wound Matrix?
The product can be stored at room temperature
(10-30 degrees C).
How is the product sold?
INTEGRA™ Flowable Wound Matrix is sold
as a 1 pack kit containing one syringe with granular collagen,
one sterile 10cc syringe, one flexible injector and luer
lock connector.
What is the shelf life of INTEGRA™ Flowable Wound Matrix?
The product shelf life is 18 months from
date of manufacture. Lot number and expiration date information
are included on the packaging.
Is INTEGRA™ Flowable Wound Matrix latex-free?
All raw materials used in the manufacture
of INTEGRA™ Flowable Wound Matrix, including packaging
and accessories, are not formulated with and do not contain
any natural rubber latex or dry natural rubber in accordance
with US FDA Regulations (21 CFR Section 801.437).
Is training required before use of the
INTEGRA™ Flowable Wound Matrix?
Training is recommended prior to using
INTEGRA™ Flowable Wound Matrix. The training program
consists of a review of the Physician Training CD with
your local Plastic and Reconstructive Sales Specialist
or review of this website. Participation in the training
program will result in certification and the assignment
of a certification number.
Are there any contraindications for the
product?
The device should not be used in patients
with known sensitivity to bovine collagen or chondroitin
materials.
INTEGRA™ Flowable Wound Matrix is not
indicated for use in third-degree burns.
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