Contraindications; Instructions For Use - NuMED CP STENT Mode D'emploi

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.
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.
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.
• 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 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.
• 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.
PRECAUTIONS
• Use of an inflation device with pressure gauge is highly recommended during this procedure.
• The stent is rigid and may make negotiation through vessels difficult.
• Dilatation procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment.
• Guidewires are delicate instruments. Care should be exercised while handling to help prevent the possibility
of breakage.
• Careful attention must be paid to the maintenance of tight catheter connections and by aspiration before
proceeding to avoid air introduction into the system.
• Under no circumstances should any portion of the catheter system be advanced against resistance. The
cause of the resistance should be identified with fluoroscopy and action taken to remedy the problem.
POTENTIAL COMPLICATIONS/ADVERSE EFFECTS
NOTE: Circumferential tear of the delivery balloon catheter prior to complete expansion of the stent may cause
the balloon to become tethered to the stent, requiring surgical removal. In case of rupture of an adequately sized
balloon after stent expansion, it can be withdrawn and a new balloon catheter exchanged over a guidewire to
complete expansion of the stent.

Instructions for Use

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