COOK Medical Zilver PTX Instrucciones De Uso página 3

ZILVER® PTX® DRuG ELuTING PERIPHERaL STENT
CauTION: u.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
The Zilver PTX Drug Eluting Peripheral Stent is a self-expanding stent made of
nitinol and coated with the drug paclitaxel. It is a flexible, slotted tube that is
designed to provide support while maintaining flexibility in the vessel upon
deployment. Post-deployment, the stent is designed to impart an outward
radial force upon the inner lumen of the vessel, establishing patency in the
stented region.
The stent is preloaded in a 7.0 French delivery catheter. Hand-loading of the
stent is not possible. Stent deployment is controlled by retraction of the handle
while holding the metal cannula stationary.
MRI CONDITIONS
Non-clinical testing has demonstrated that the Zilver PTX Drug Eluting
Peripheral Stent is MR Conditional. It can be scanned safely under the
following conditions:
• Static magnetic field of 3 Tesla or less
• Spatial gradient field of 720 Gauss/cm or less
• Whole body averaged specific absorption rate (SAR) of 1.5 W/kg (for a single
stent at 1.5 Tesla) and 3 W/kg (for a single stent at 3 Tesla and a pair of
overlapping stents at 1.5 and 3 Tesla) for 20 minutes (for a single stent at 1.5
Tesla) and 15 minutes of scanning (for a single stent at 3 Tesla and a pair of
overlapping stents at 1.5 and 3 Tesla), respectively.
In non-clinical testing, the Zilver PTX Drug Eluting Peripheral Stent produced
a maximum temperature rise of 3.8 degrees C (testing performed on a single
stent at 1.5 Tesla, a pair of overlapping stents at 1.5 Tesla, a single stent at 3
Tesla, and a pair of overlapping stents at 3 Tesla) at whole body averaged
specific absorption rates (SAR) of 1.5 W/kg (for a single stent at 1.5 Tesla) and
3 W/kg (for a single stent at 3 Tesla and a pair of overlapping stents at 1.5 and
3 Tesla) for 20 minutes (for a single stent at 1.5 Tesla) and 15 minutes (for a
single stent at 3 Tesla and a pair of overlapping stents at 1.5 and 3 Tesla) of
MR scanning in a 1.5 Tesla/64 MHz Magnetom Siemens Medical Solutions MR
scanner and a 3 Tesla Excite General Electric MR scanner.
MR image quality may be compromised if the area of interest is in the exact
same area or relatively close to the position of the Zilver PTX Drug Eluting
Peripheral Stent. Therefore, it may be necessary to optimize MR imaging
parameters for the presence of this metallic implant.
Heating in the MRI environment for stents with fractured struts is not known.
INTENDED USE
The Zilver PTX Drug Eluting Peripheral Stent is intended for use in the
treatment of symptomatic vascular disease of the above-the-knee
femoropopliteal arteries having reference vessel diameter from 4 mm to 9 mm.
To avoid involvement of the common femoral artery, the proximal end of the
stent should be placed at least 1 cm below the origin of the superficial femoral
artery. To avoid involvement of the below-the-knee popliteal artery, the distal
end of the stent should be placed above the plane of the femoral epicondyles.
CONTRAINDICATIONS
• Stenoses that cannot be dilated to permit passage of the introducer catheter.
• Stenting of an arterial vessel where leakage from the artery could be
exacerbated by placement of a stent.
• Patients with bleeding disorders.
• Women who are pregnant, breastfeeding, or plan to become pregnant in the
next 5 years should not receive a Zilver PTX Drug Eluting Peripheral Stent. It
is unknown whether paclitaxel will be excreted in human milk, and there is a
potential for adverse reaction in nursing infants from paclitaxel exposure.
WARNINGS
• Persons with allergic reactions to nitinol may suffer an allergic reaction to this
implant.
• Persons allergic to paclitaxel may suffer an allergic reaction to this implant.
• The effect of implanting more than four Zilver PTX Drug Eluting Peripheral
Stents in a patient has not been clinically evaluated.
PRECAUTIONS
• This product is intended for use by physicians trained and experienced in
diagnostic and interventional vascular techniques. Standard techniques for
interventional vascular procedures should be employed.
• Manipulation of the Zilver PTX Drug Eluting Peripheral Stent requires
fluoroscopic control.
• Do not try to remove the stent from the introducer system before use.
• Ensure that the red safety lock is not inadvertently removed until final stent
release.
• Deploy the stent over an extra stiff or ultra stiff wire guide.
• Do not attempt to push the handle away from the hub during deployment.
• Do not expose the delivery system to organic solvents (e.g., alcohol).
• Do not use power injection systems with the delivery system.
• Do not rotate any part of the system during deployment.
• The device is intended for single use only. Do not resterilize and/or reuse this
device.
• Repositioning of the device after deployment is not possible since the
introducer catheter cannot be re-advanced over the stent once deployment
begins.
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