Product Description - Vascular Restorer CoCr Instructions D'utilisation

therapies for living

1. Product description

The LVD Biotech SL peripheral stent is a stent manufactured with a L605 Cobalt-Chrome alloy. The stent
is pre-mounted in the delivery system that will expand it by means of a balloon, in the peripheral artery to
be treated.
The stent is designed to be implanted in different artery diameters through adaptation of its open cell de-
sign with alternating connection points. The stent is manufactured by laser cutting of metal tubes. It then
undergoes various treatments to give the surface a smooth, shiny finish.
The stent's delivery system consists in a double-lumen shaft balloon catheter from the proximal luer hub
to the distal tip, also known as OTW, designed for percutaneous transluminal angioplasties of peripheral
arteries.
At the most distal end, the catheter has a balloon of a specific diameter and length, so that it couples the
different stent configurations. When the balloon is inflated by means of contrast medium injection inside it,
it dilates the stent and places it against the artery. Afterwards, the balloon is deflated and withdrawn, and
the stent is permanently implanted.
The proximal luer hub is "Y-shaped" and it has two entry ports:
- The lateral port allows entry of contrast medium to dilate the stent.
- The straight port is the passage port for the guidewire. The guidewire is introduced in the luer hub's
entry port and it goes out through the catheter's tip to lead it to the lesion location.
Likewise, there is a guidewire passage lumen and a lumen for contrast medium passage into the balloon, in
direct connection with each of the luer hub ports.
The guidewire diameter must not exceed 0.89 mm = 0.035 inches.
The catheter's useful length may be 80 cm or 140 cm depending on the reference.
The stent may have the following diameters and lengths:
18
28
38
58
The balloon is designed to reach different diameters at different pressures (according to the compliance
curve included in the primary package).
In order to inflate the balloon, it is necessary to connect theluer hub's inflation port to a syringe (indefla-
tor) which a manometer included. With the pressure indicated by the manometer, the balloon is inflated
2
INSTRUCTIONS FOR USE
PERIPHERAL STENT SYSTEM CoCr
STENT DIAMETERS (mm)
5 6
X X
X X
X X
X X
7 8
X X
X X
X X
X X
restorer
9 10
X X
X X
X X
X X