Contraindications; Instructions For Use - NuMED MOUNTED CP STENT Gebrauchsanweisung

ENGLISH
INDICATIONS
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.
DESCRIPTION
The CP Stent is balloon expandable and intended for permanent implant. The 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 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

• 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.
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.
BIB STENT PLACEMENT WARNINGS
• Do not exceed the RBP. An inflation device with pressure gauge is recommended to monitor pressure.
Pressure in excess of the RBP can cause balloon rupture and potential inability to withdraw the catheter
through the introducer sheath.
• Confirm that the distal end of the introducing sheath is at least 2.5cm back from the most proximal image
markers before inflating the outer balloon. Failure to do so may stretch the outer tubing and severely hinder
balloon deflation.
• Use two appropriate size inflation devices with pressure gauges for inflation.
• Do not advance the guidewire, balloon dilatation catheter, or any other component if resistance is met,
without first determining the cause and taking remedial action.
• This catheter is not recommended for pressure measurement or fluid injection.
• Do not remove the guidewire from the catheter at any time during the procedure except when the procedure
has been completed.

INSTRUCTIONS FOR USE

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