How Supplied; Instructions For Use - NuMED NuCLEUS-X Instrucciones De Utilizacion

ENGLISH
I :
NDICATIONS
Recommended for Percutaneous Transluminal Valvuloplasty (PTV) for mitral and aortic
positions. The use of this catheter is particularly indicated in stenosis where difficulty in bal-
loon positioning during inflation is experienced.
D :
ESCRIPTION
NuMED's NuCLEUS-X PTV Catheter design features a single dilation balloon on a coaxial
catheter shaft. This balloon features a smaller 'waist' segment at its midpoint to facilitate
locking into the valve or other area to be dilated. This 'waist' area will expand to 90% of the
rated balloon diameter upon injection of the inflation volume. The extension labeled with the
balloon size and the product lot number is for balloon inflation/deflation. The other 'Y'
connector port is used for passage of the guidewire.
The catheter's inner tip is manufactured of thermoplastic tubing and is marked with three
radiopaque markers located at the 'waist' center and beneath the shoulders of the balloon to
define the balloon position.
Each balloon inflates to the stated diameter and length at a specific pressure. The balloon
size is ± 10% at the 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.
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
In addition to the standard risks associated with insertion of a cardiovascular catheter, the
below contraindications apply:
Contraindications for Aortic Balloon Valvuloplasty:
• Aortic Stenosis
• Moderate to Severe Aortic Valve Regurgitation
Contraindications for Mitral Balloon Valvuloplasty:
• Mild Mitral Stenosis
• Moderate to Severe Mitral Regurgitation
The patient's medical condition could affect successful use of this catheter.
W :
ARNINGS
• CAUTION: 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.
• Catheter balloon inflation diameter must be carefully considered in selecting a
particular size for any patient. The inflated balloon diameter should not be significantly
greater than valvular diameter. The choice of the balloon size to be used for valve stenosis
has been established by the VACA Registry to be approximately 0.9 to 1.0 times the valve
annulus. It is important to perform an angiogram prior to valvuloplasty to measure the size of
the valve in the lateral projection.
Balloons longer than 4cm are not recommended for children ≤ 10 years old.
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Instructions for Use:

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