How Supplied; Instructions For Use - NuMED CP STENT Instrucciones De Utilizacion

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 adjacent vessel diameter. Stenosis that would present
increased risk of vascular damage or 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.
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.
W
ARNINGS
• As with any type of implant, infection secondary to contamination of the stent may lead
to aortitis, or abscess. The platinum/iridium stent may migrate from the site of implant.
Over-stretching of the artery may result in rupture or aneurysm formation.
• When the stent is crimped onto a balloon delivery catheter, the maximum balloon
inflation pressure must not exceed the recommended inflation pressure specified in the
manufacturer's instructions.
• The inflation diameter of the balloon used during stent delivery should approximate the
diameter of the obstructive vessel and the intended implant site.
• Excessive force while crimping may weaken welds of the stent.
• This device is intended for single use only. Do not resterilize and/or reuse it, as this
can potentially result in compromised device performance and increased risk of cross-
contamination.

Instructions for Use:

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