COOK Medical Zilver, Инструкция по эксплуатации

Страница: 5 / 32

5
ENGLISH
ZILVER
®
VASCULAR STENT
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician
(or properly licensed practitioner).
Do not re-sterilize.
DEVICE DESCRIPTION
The Zilver® Vascular Stent is a self-expanding stent made of nitinol. 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 Zilver Vascular Stent is available in the following sizes:
Stent
Outer
Diameter
(mm)
5 French (1.67 mm)
Delivery System
6 French (2.0 mm)
Delivery System
7 French (2.3 mm)
Delivery System
Stent Length (mm)
20 30 40 60 80 20 30 40 60 80 20 30 40 60 80
6 × × × × × × × × × × × × × × ×
7 × × × × × × × × × × × × × × ×
8 × × × × × × × × × × × × × × ×
9 × × × × × × × × × × × × × × ×
10 × × × × × × × × × × × × × × ×
The Zilver stent comes preloaded in 7.0, 6.0 and 5.0 French (2.3, 2.0 and 1.67 mm) delivery
catheters. Hand-loading of the stent is not possible. Stent deployment is controlled by
retraction of the handle while holding the metal cannula stationary.
INDICATIONS FOR USE
The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal
angioplasty (PTA) in the treatment of symptomatic vascular disease of the iliac arteries up to
100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable
candidates for PTA and/or stent treatment.
CONTRAINDICATIONS
There are no contraindications known at this time based on the clinical data.
WARNINGS
Persons allergic to nitinol (nickel titanium) may suffer an allergic reaction to this implant.
PRECAUTIONS
• This product should only be used by physicians trained and experienced in diagnostic
and interventional vascular techniques. Standard techniques for interventional vascular
procedures should be employed.