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ZILVER FLEX™35 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 FLEX™35 Vascular Stent (ZFV) is a self-expandable stent made of nitinol. The
special laser-cut pattern of the nitinol tube provides a construction with a strong radial force
and high flexibility.
The stent has radiopaque markers at both ends (i).
The stent is supplied preloaded in a 6.0 French (2.0mm) introducer catheter. A radiopaque
marker (h) on the distal tip of the sheath is used to visualize deployment of the stent. Stent
deployment is controlled by means of a hand-held device.
Refer to Stent Size Selection Table below.
Stent Length (mm)
Delivery System (cm)
Stent Length (mm)
Delivery System (cm)
Stent Outer
Diameter (mm)
INTENDED USE
The product is intended for use in the iliac, superficial femoral artery (SFA) and above-the-
knee popliteal artery for the following treatments:
20
80
125
80
5
x
x
x
6
x
x
x
7
x
x
x
8
x
x
x
9
x
x
x
10
x
x
x
100
80
125
80
5
x
x
x
6
x
x
x
7
x
x
x
8
x
x
x
9
x
x
x
10
x
x
x
30
40
125
80
125
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
120
140
125
80
125
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
9
ENGLISH
60
80
80
125
80
125
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
170
200
80
125
80
125
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
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