Instructions For Use; How Supplied - INVATEC IN.PACT PACIFIC Instrucciones De Uso

PHARMACOLOGICAL INTERACTION
Due to the low dosage and local administration pharmacological
interactions are not to be expected.
Pharmacological interactions have not been reported.
INSTRUCTION FOR USE
Prior to angioplasty, carefully examine all equipment to be used during
the procedure, including the dilatation catheter, to verify proper function.
Verify that the catheter and sterile packaging have not been damaged in
shipment and that the catheter size is suitable for the specific procedure
for which it is intended.
Handle the device with extreme caution in order to avoid any
damage to the folded balloon. Moistening of the device with
saline, insertion through the sheath and contact with blood will
not reduce the efficacy of the FreePac™ coating as long as the
balloon remains uninflated.
1. Inflation Device Preparation
a. Prepare the inflation device according to the manufacturer's
instructions.
b. Carefully remove the balloon protective sheath. Prior to use,
carefully examine the unit to verify that the catheter or sterile
package has not been damaged in shipment. In case of resistance,
twist the protection with one hand holding the shaft with the other.
2. Dilatation Catheter Selection
a. The nominal balloon size must be chosen equal to the inner
diameter of the artery distal to the lesion. If the stenosis cannot be
crossed with the desired dilatation catheter, use a smaller diameter
(non drug coated) catheter to pre-dilate the lesion to facilitate
the passage of a more appropriate-sized dilatation catheter.
b. In cases of total occlusion or subocclusive lesions a predilatation
with a (non drug coated) balloon is recommended.
3. Dilatation Catheter Preparation
a. The catheter is packaged in a protective hoop; carefully remove
the catheter from the package.
b. The folded balloon catheter contains tiny air bubbles that should
be purged prior use. To do this, keep the balloon catheter in a
downward vertical position. Keep the protective sheath in place
during the purging procedure. Connect a Luer-lock syringe partially
filled with saline-contrast mixture solution to the inflation port of
the catheter hub. Apply negative pressure for 15 seconds until
air is completely evacuated and release the plunger. Repeat this
operation a couple of times until migration of air bubbles towards
the syringe stops. Never use air or any gaseous medium to inflate
the balloon. Use only the recommended inflation medium. Never
apply positive pressure to the balloon during preparation.
c. Remove the stylet and the protective sheath from the balloon.
d. Flush the wire lumen properly through the connector luer hub.
4. Inflation Device connection to Catheter
a. To remove any air lodged in the distal Luer fitting of the inflation
device, purge approximately 1 ml (cc) of contrast medium.
b. With the stopcock in the closed position, disconnect the syringe
used in preparation applying a slight positive pressure. A meniscus
of contrast medium will appear in the balloon port when the syringe
is removed. Verify that a meniscus of contrast medium is evident
in both the dilatation catheter balloon port (hub) and the inflation
device connection. Securely couple the inflation device to the
balloon port of the balloon dilatation catheter.
5. Use of the IN.PACT™ PACIFIC PTA Balloon Angioplasty Catheter
a. Insert a guidewire through the hemostatic valve following the
manufacturer's instructions or standard practice. Advance the
guidewire carefully into the guiding catheter/ introducer sheath.
When complete, withdraw the guidewire/ introducer, if used.
b. Attach a torque device to the wire, if desired. Under fluoroscopy,
advance the guidewire to the desired vessel, then across the
stenosis.
c. Thoroughly aspirate and flush the guiding catheter in preparation
(when guiding catheter is used) for introduction of the dilatation
catheter. Back load the distal tip of the dilatation catheter onto the
guidewire.
NOTE: To avoid kinking, advance the dilatation catheter slowly, in
small increments until the proximal end of the guidewire emerges
from the catheter.
d. Advance the catheter through the hemostatic valve slowly, while
the balloon is fully deflated. It should be observed that
the hemostatic valve is only closed as much as to prevent blood
return yet permitting easy movements of the dilatation catheter.
If resistance is encountered, do not advance the catheter through
the adapter.
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e. Under fluoroscopy, use the balloon radiopaque markers to position
the balloon within the lesion to be dilated and inflate the balloon
to the appropriate pressure (refer to balloon compliance table).
f. The majority of the drug is released within the first 30 seconds
of balloon inflation. The duration of the inflation should therefore
be between 30 seconds and 1 minute for optimal drug release.
In order to optimize lesion dilatation, longer inflation times are
possible at the discretion of the operator.
g. Maintain negative pressure on the balloon between inflations.
h. Completely deflate the balloon catheter. Withdraw the deflated
dilatation catheter and guidewire from the guiding catheter /
introducer sheath, through the hemostatic valve. Tighten the
knurled knob on the hemostatic valve.
i. If necessary the balloon catheter can be exchanged over the
guidewire which remains in the vessel, for different balloon types
or sizes. Alternatively the catheter can be used as an infusion
catheter.
j. WARNING: The same vessel segment must not be dilated with more
than one IN.PACT™ PACIFIC. Should a postdilatation be necessary
after the utilization of an IN.PACT™ PACIFIC balloon, so should this
be done with a standard (non drug coated) dilatation balloon. Drug
Eluting Stents must not be implanted into the vessel segment that
has been treated with an IN.PACT™ PACIFIC balloon.
k. If more than one balloon is required to treat a single lesion balloons
must overlap by at least 1 cm. A second new balloon catheter has
to be used because the drug is almost completely released during
the first expansion. Additional overlapping should be avoided.
6. Pre- and postprocedure antiplatelet regimen
a. Dual antiplatelet therapy (ASS and clopidogrel or ticlopidine) should
be administered pre-procedure and for a minimum of 4 weeks
after the intervention. Prolonged antiplatelet therapy can be given
at the discretion of the physician and should be considered after
placement of stents.

HOW SUPPLIED

The IN.PACT™ PACIFIC PTA balloon catheter is supplied sterile and
intended for single use only. The IN.PACT™ PACIFIC is sterilized
by ethylene oxide gas. It will remain sterile as long as the packaging
remains unopened and undamaged. Use product prior to labeled
Expiration Date.
CAUTION: Do not use if the inner package is open or damaged.
STORAGE
Store at controlled room temperature, in a dry place. Keep away from
sunlight. Do not expose to organic solvents (e.g. alcohol), ionizing
radiation or ultraviolet light. Rotate inventory so that catheters are used
prior to the expiration date on package label.
WARRANTY/LIABILITY
The product and each component of its system have been designed,
manufactured, tested and packaged with all reasonable care. The
warnings contained in Invatec's instructions for use are expressly to
be considered as an integral part of this provision. Invatec guarantees
the product until the expiry date indicated on the same. The warranty
is valid provided that the use of the product was consistent with the
instructions for use. Invatec disclaims any warranty of merchantability
or fitness for a particular purpose of the product. Invatec is not
liable for any direct, indirect, incidental or consequential damages
caused by the product. Except in the case of fraud or grave fault on
Invatec's part, compensation of any damage to the buyer will not, in
any event, be greater than the invoice price of the disputed products.
The guarantee contained in this provision incorporates and substitutes
the legal guarantees for defects and compliance, and excludes any
other possible liability of Invatec, however originating, from the product
supplied. These limitations of liability and warranty are not intended to
contravene any mandatory provisions of law applicable. If any clause
of the disclaimer is considered by a competent court to be invalid or to
be in conflict with the applicable law, the remaining part of it shall not
be affected and remain in full force and effect. The invalid clause shall
be substituted by a valid clause which best reflects Invatec's legitimate
interest in limiting its liability or warranty. No person has any authority to
bind Invatec to any warranty or liability regarding the product.
Due to biological variability between different individuals no product can
be 100% effective under all conditions. For this reason and as Invatec
has no influence on the diagnosis of the patients, the methods applied,
and the handling of the device after it has left the Invatec warehouse,
Invatec does not guarantee the effectiveness nor the absence of
complications associated with its use.
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