Surgitime PTFE – CE 0434
Barriers
DESCRIPTION
AND ACTION FOUNDATIONS
Surgitime PTFE is 100% biocompatible and synthetic
origin. Considered as barriers for tissue regeneration, they are utilized in
regenerative techniques both in the medical and in the odonthological areas,
they have memory and may be pre-molded to the defect and attached with screws
for grafting and Bionnovation fixation on the bone surface, however it’s not
necessary to use the Screw for grafting so that Surgitime may exercise its function,
and its use varies according to the choice made by the professional surgeon
employing it.
Surgitime PTFE or mechanical barriers for Guided
Tissue Regeneration (GTR) are used to prevent migration of cells from
epithelial and connective tissues, what would cause bone growth inhibition,
thus providing a proper space for the formation of a natural fibrin structure,
which is the bone tissue precursor. The membrane prevents competition between
connective tissue and bone, and has the purpose of isolating bone grafts
promoting tissue regeneration. They come in different lengths and widths,
providing adequate choices and uses for each surgical procedure.
In
odonthological procedures, it’s necessary to undertake a second surgery to
withdraw them, and they may remain in site for at least 21 days, the time
necessary to start osteoconduction.
INDICATIONS
AND PURPOSE OF USE
The Surgitime
PTFE are destined to regenerative techniques in periodontics, implantology,
orthopedics, neurosurgery or any medical and odonthological surgical procedure
that requires a mechanical barrier, such as the treatment of horizontal and
vertical periodontal defects, new bone formation in alveolar ridges, protection
against epithelial invagtination in sinus elevation procedures, and formation
of proximal areas around odonthological grafting. The Surgitime PTFE devices
keep the grafting material in position, without any prejudice to the properties
of both, they also keep the clot in the surgical site (in case it does not
utilize any biomaterial), they segregate cells and microorganisms that might
interfere with bone neoformation, and allow for good vascularization and
nutrition of the grafting material. They are available in many different
formats to provide better adaptation to the receptor site, and they may also be
freely conformed through the help of scissors or a sterile scalpel.
PRECAUTIONS,
RESTRICTIONS, WARNINGS
1.
STERILE
– The product is sterile as long as package integrity, validity term and storage
conditions are observed.
2.
Professional
use only is the responsibility of the dentist or doctor their prior training to
use this product. Only qualified professionals with expertise in surgical
techniques and procedures necessary for proper use of the product should make
use of Surgitime PTFE. The use of incorrect surgical techniques may cause
discomfort as painful sensation, hypoesthesia, edema
3.
DO
NOT RESTERILIZE AND REPROCESS IT – if it is resterilized or reprocessed its
physical-chemical properties may be altered, leading to foreign body reaction.
4.
PROHIBITED
REUSE - If reused or used with expired
validity, may cause irritation, inflammation and other adverse events,
compromising the health and safety of the patient.
5.
The
use of the product under inadequate surgical techniques and biosafety
conditions may harm the patient leading to unsatisfactory results.
6.
ALWAYS
STERILIZE THE INSTRUMENTS BEFORE USING THEM.
7.
The
clinical and radiographic evaluation must be done prior to surgery, to help the
correct treatment planning. Determination of bone quality and quantity, repairs
and anatomical structures and analysis of neighbouring teeth.
8.
In
all surgeries involving Surgitime PTFE must be observed proper techniques used
for asepsis and antisepsis.
9.
The
abuse of alcohol, tobacco, drugs, steroids or lack of proper oral hygiene can
significantly impair the success of the treatment.
10.
All potential adverse effects as
dehiscence, inflammation, bone loss, haemorrhage, must be previously informed
to the patient.
11.
It is supplied in sterile
condition and once opened should be used in aseptic conditions. Should always
work with sterile fields, appropriate instruments to the procedure and in good
condition in order to eliminate sources of infection and damage to the product.
12.
Surgitime PTFE should be used
only for the purpose for which it is intended.
13.
The membrane exposure may occur
in dental procedures, when no perfect adaptation to the receiving bed or the
covering tissues occurs.
14.
We also recommend in
odonthological procedures a second surgery to remove Surgitime. Surgitime’s
withdrawal varies according to the choice and under the responsibility of the
professional surgeon.
15.
If occur complications impossible
to be controlled, tissue inflammation or evidence of infection is recommended
the immediate removal of the material.
16.
Surgitime PTFE is provided in
sterile double packaging (Ethylene Oxide – ETO). Provided the packaging’s
integrity has not been somewhat compromised, it will keep the product sterile
for up to 3 years to be counted as of the sterilization date.
17.
There are no restrictions as to
maximum amount of product that can be deployed. The amount will be determined
by the professional after analyzing the size of the surgical site.
18.
The surgeon shall evaluate its
indication to patients diagnosed with diseases or that use a medication that
might change the reparation metabolism
19.
The remaining material on the
bottle may not be reused, resterilized or reprocessed. Dispose of it in a
de-characterized way, according to the current legislation for hospital waste.
20.
In cases of adverse effects
occurring in patients, the responsible must contact immediately with the SAC
Bionnovation (Customer Service) by the number 0800 707 3824 or by e-mail
sac@bionnovation.com.br. The Bionnovation Biomedical Products is responsible
for notifying the ANVISA (Health Surveillance Agency) about the relevant
occurences according to internal technovigilance procedure.
21.
Surgitime
PTFE sas developed in order to prevent that its use does not compromise the
clinical condition of patients as well as their safety.
Note:Bionnovation suggests that the product’s 5 identification adhesive labels with
numbers are attached to patient documentation (patient’s clinical dossier,
report given to the patient, sale invoice of the product, supplier control and
surgeon control). This assures full product traceability through the ID code
and batch printed in the labels, and prompt location of all production
documents; then the product can be retained for evaluation and analysis puposes
when needed.
CONTRA
INDICATIONS
1.
Surgitime PTFE, like all the
other membranes, should not be placed on existing active infection or in case
of any other degenerative disease that can affect membrane implant.
2.
It must not be utilized in
patients that are not able, under the clinical point of view, to be submitted
to a medical or odonthological intervention. Such as, for example, in patients
with uncompensated diabetes.
3.
It’s contraindicated for
procedures different from those recommended in item "Use Indication”.
4.
Do
not expose the Surgitime PTFE to the environment.
SPECIAL CONDITIONS FOR THE
PRODUCT’S STORAGE AND TRANSPORTATION, CONSERVATION AND/OR HANDLING
Storage
and Transportation
Store and
transport the product away from direct sunlight, and from heat and humidity.
Keep the packaging sealed until its utilization time. Do not use it if the
sterile package has been opened, or if it’s damaged, or if the sterilization
validity date has expired in order to avoid possible contamination. Discard any
mischaracterized product according to the applicable legislation for hospital
waste, or return the damaged packages to the factory, including the device.
Conservation
and Handling
In case of any
alteration in the Surgitime PTFE characteristic that might have mischaracterized
it, please discard it according to the applicable legislation for hospital
waste, or return the damaged packages to the factory, including the device.
USE
INSTRUCTIONS
1.
Place
the package contents on a sterile surgical field.
2.
Detach
the flap so that later the membrane exceeds at least 2 mm the area to be
protected.
3.
Using
the aseptic surgery techniques applicable in the case, prepare the receiving
bed for the membrane.
4.
Cut
the membrane in a suitable size, with the aid of a sterile pair of scissors,
aiming maximum adaptation.
5.
Adapt
the membrane to the site, observing its margins. All of it should be over soft
tissue and without folds.
6.
Re-place
the flap over the membrane.
7.
Suture
without involving the membrane. Only in cases of use for medical field, the
membranes can be involved.
8.
Using
surgical cement is facultative to the surgeon in charge.
9.
Antibiontics,
painkillers or anti-inflammatory drugs may be used after surgery.
10.
The
membrane can be removed once its purpose is accomplished.