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FORMULA 418®
VASCULAR BALLOON-EXPANDABLE STENT SYSTEM
DEVICE DESCRIPTION
The Formula 418 Vascular Stent is a balloon-expandable stent made of 316L stainless steel with a slotted tube
configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system (Formula
418 Vascular Balloon-Expandable Stent System). The stent is positioned between two radiopaque marker bands,
which are located inside the balloon at the proximal and distal tapers of the balloon. The cannula design of the stent
provides a low outside diameter profile, which permits use with a 5.0 French sheath or 6.0 French guiding catheter for
3-6 mm diameter sizes and a 6.0 French sheath and 7 French guiding catheter for 7-8 mm diameter sizes. The Formula
418 Vascular Balloon-Expandable Stent System is pre-mounted on 80 cm and 135 cm over-the-wire balloon catheter
delivery systems. The stent is available in nominal expanded diameters of 3, 4, 5, 6, 7, and 8 mm with lengths of 12,
16, 20, 24 and 30 mm each. (Table 1)
Order Number
FOV418-18-80-3-12
FOV418-18-80-3-16
FOV418-18-80-3-20
FOV418-18-80-3-24
FOV418-18-80-3-30
FOV418-18-80-4-12
FOV418-18-80-4-16
FOV418-18-80-4-20
FOV418-18-80-4-24
FOV418-18-80-4-30
FOV418-18-80-5-12
FOV418-18-80-5-16
FOV418-18-80-5-20
FOV418-18-80-5-24
FOV418-18-80-5-30
FOV418-18-80-6-12
FOV418-18-80-6-16
FOV418-18-80-6-20
FOV418-18-80-6-24
FOV418-18-80-6-30
FOV418-18-80-7-12
FOV418-18-80-7-16
FOV418-18-80-7-20
FOV418-18-80-7-24
FOV418-18-80-7-30
FOV418-18-80-8-12
FOV418-18-80-8-16
FOV418-18-80-8-20
FOV418-18-80-8-24
FOV418-18-80-8-30
FOV418-18-135-3-12
FOV418-18-135-3-16
Table 1: Device Specifications (diameters and lengths)
Catheter
Stent
Length
Diameter
(cm)
(mm)
80
3
80
3
80
3
80
3
80
3
80
4
80
4
80
4
80
4
80
4
80
5
80
5
80
5
80
5
80
5
80
6
80
6
80
6
80
6
80
6
80
7
80
7
80
7
80
7
80
7
80
8
80
8
80
8
80
8
80
8
135
3
135
3
Minimum Guiding
Stent
Catheter/Sheath*
Length
Inside Diameter
(mm)
12
16
20
24
30
12
16
20
24
30
12
16
20
24
30
12
16
20
24
30
12
16
20
24
30
12
16
20
24
30
12
16
3
ENGLISH
Guiding
Catheter/
Sheath
(French
(inches)
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.068
6.0/5.0
0.078
7.0/6.0
0.078
7.0/6.0
0.078
7.0/6.0
0.078
7.0/6.0
0.078
7.0/6.0
0.078
7.0/6.0
0.078
7.0/6.0
0.078
7.0/6.0
0.078
7.0/6.0
0.078
7.0/6.0
0.068
6.0/5.0
0.068
6.0/5.0
size)
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