Coarctation Of The Aorta; Right Ventricular Outflow Tract; Instructions For Use - NuMED COVERED MOUNTED CP STENT Gebrauchsanweisung

ENGLISH
INDICATIONS
Coarctation of the Aorta (CoA)
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 or disruption; or aneurysm associated with coarctation of the aorta.
Right Ventricular Outflow Tract (RVOT)
Indicated for treatment of right ventricle to pulmonary artery (right ventricular outflow tract) conduit disruptions
that are identified during conduit pre-dilatation procedures performed in preparation for transcatheter pulmonary
valve replacement.
DESCRIPTION
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.
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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.
HOW SUPPLIED
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.
CONTRAINDICATIONS – CoA and RVOT
• 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 (CoA only);
• Occlusion or obstruction of systemic artery precluding delivery of the stent (CoA only);
• Clinical or biological signs of infection;
• Active endocarditis;
• Known allergy to aspirin, other antiplatelet agents, or heparin (CoA only);
• Pregnancy.
CP STENT WARNINGS
• Radiofrequency heating during MRI scans on overlapped, 10 zig CP Stents has not been evaluated.
• 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.
• The inflated diameter of the stent should at least equal the diameter of the intended implant site.
• Excessive force while crimping may weaken welds of the stent.
• Crimping the 8 zig stent on a balloon catheter smaller than 12mm, and the 10 zig on a balloon catheter
smaller than 26mm, may cause damage to the stent.
• Excessive handling and manipulation of the covering while crimping the stent may cause the covering to tear
off of the stent.
• Crimping the device in the opposite direction of the folds in the covering may cause the covering to catch while
inserting into the hemostasis valve tool and introducer. This could cause the covering to tear off of the stent.
• Pulling the Covered stent back through the introducer and/or hemostasis valve may cause the covering to
catch and tear off of the stent.

Instructions for Use

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