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ENGLISH
I
NDICATIONS
Indicated for implantation in the native and/or recurrent coarctation of the aorta on patients
with the following clinical conditions:
•
Stenosis of the aorta resulting in significant anatomic narrowing as determined by
angiography or non-invasive imaging, i.e. echocardiography, magnetic resonance
imaging (MRI), CT scan;
•
Stenosis of the aorta resulting in hemodynamic alterations, resulting in systolic
pressure gradient, systemic hypertension or altered left ventricular function;
•
Stenosis of the aorta where balloon angioplasty is ineffective or contraindicated;
•
Stenosis diameter <20% of the adjacent vessel diameter. Stenosis that would present
increased risk of vascular damage of disruption; or aneurysm associated with
Coarctation of the aorta.
D
ESCRIPTION
The Covered CP Stent is balloon expandable and intended for permanent implant. The
Covered CP Stent is composed of heat treated 90% platinum/10% iridium wire that is
arranged in laser welded rows with a "zig" pattern. The number of zigs in a row can be
varied and will impact the strength of the stent as well as the eventual expanded diameter
and percent stent shortening, while the number of rows will determine the unexpanded
length of the stent. The Covered CP Stent has an ePTFE covering attached to the stent
framework. This covering acts as a fluid barrier creating a fluid tight conduit through the
stent length.
The NuMED BIB® (Balloon in Balloon) Catheter is a triaxial design catheter. Two lumens are
used to inflate the balloons while one lumen is for tracking over a guidewire. The radiopaque
platinum marker(s) are placed beneath the 'working area' of the balloon. The inner balloon is
½ of the outer balloon diameter and 1 cm shorter. Each balloon inflates to the stated
diameter and length at a specific pressure. The balloon size is ±10% at rated burst pressure
(RBP). The RBP is different for each size. Check the package label for the RBP. It is
important that the balloon not be inflated beyond the RBP.
The purpose of the double balloon catheter is to apply an incremental inflation for the
purpose of opening a vascular channel using a balloon expandable intravascular stent. The
inner balloon provides initial expansion of the stent and also acts as a tool to hold the stent
in place while the outer balloon is inflated. The outer balloon is then inflated securing the
stent against the vessel wall.
H
S
OW
UPPLIED
Supplied sterilized by ethylene oxide gas. Sterile and non-pyrogenic if package is unopened
or undamaged. Do not use the product if there is doubt as to whether the product is sterile.
Avoid extended exposure to light. Upon removal from package, inspect the product to
ensure no damage has occurred.
C
ONTRAINDICATIONS
•
Patients too small to allow safe delivery of the stent without compromise to the
systemic artery used for delivery;
•
Unfavorable aortic anatomy that does not dilate with high pressure balloon angioplasty;
•
Occlusion or obstruction of systemic artery precluding delivery of the stent;
•
Clinical or biological signs of infection;
•
Active endocarditis;
•
Known allergy to aspirin, other antiplatelet agents, or heparin;
•
Pregnancy.
Instructions for Use:
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