Technical Data Sheet

iVolution
DESCRIPTION
The iVascular peripheral iVolution Stent, is a stent made from a nitinol alloy laser cut tube. After
different treatments to give a smooth and shiny appearance to the surface, the stent is finished
by NanoGradientTM treatment, exclusive of iVascular, to create an outer passivation layer titanium
rich, which is very biocompatible and resistant to corrosion.
The stent is loaded into the delivery system that will release it at the site of implantation.
The stent is self-expanding, reaching its final diameter after delivery. Once delivered, it remains
exerting a continuous force on the artery wall to keep it open.

The stent design is based on a plurality of undulating rings that extend axially without connection
bridges, forming an open-cell stent.

The ends of the stent have less metal density.

At each end, the stent incorporates 4 radiopaque markers to visualize it once expanded.

The stent delivery system is a coaxial catheter with triple sheath design, consisting of:
 A guide wire lumen, with the stent accommodated at the distal end. The distal part of this
tube ends in an atraumatic tip.
 A stent support tube which prevents the stent from moving back at the time of its release.
 A retractable sheath that protects and contains the stent. When the sheath is pulled back,
the stent is deployed.
 A fixed sheath partially covers the retractable sheath and protects it, so that if the user
touches the catheter, doesn’t block the movement of the retractable sheath.
For the release of the stent, it is necessary to operate the proximal handle of the delivery
system. The handle has a locking mechanism that must be disabled to begin the release. The
release may be performed slowly, by turning the screw; or it can be performed quickly, by
pressing the button and pulling back. To inform the user, there are some icons on the handle
indicating the way of delivery along with a rule that estimates the length of the stent delivered
while the pullback button goes back. The handle is ergonomic and can be used with one hand.
At the distal part of the delivery system there are three radiopaque markers that help the user
to locate the stent both when placing over the lesion and when delivering
- 2 fix markers located proximal (the one at the support tube) and distal (the one at the tip)
to the stent, indicating its position
- One mobile marker, placed at the distal end of the retractable sheath. It is initially lined
up with the distal marker. When delivering, the marker is moving back with the retractable
sheath, giving idea about the progress on the delivery. Finally, when the stent is totally
delivery, this marker is lined up with the proximal marker.

HT SPN BC35 ed 5 October 8th 2017 Paage 1 of 2

 Technical Data Sheet

iVolution
DELIVERY SYSTEM FEATURES
Total working length 80 / 140 cm
Recommended guidewire 0.035 inches
Recommended introducer 6F
Recommended guiding catheter 8F
Radiopaque markers 2 fixed limiting the stent
1 mobile at the distal part of the retractable sheath

STENT FEATURES
STENT MATERIAL Nitinol
WALL THICKNESS 180 to 190 microns
RADIOPAQUE MARKERS 4 tantalum markers at each end of the stent
% EXPANSION SHORTENING < 5%
Circumferential radial force (at 15% 0.120 N/mm
strain)
STENT DIAMETER

% ARTERY CONTACT SURFACE 5 6 7 8 9 10

20% 16% 14% 12% 11% 10%
VESSEL ADAPTABILITY High
SIZES
Lenght [mm]
40 60 80 100 150 200
5 x x x x x x
6 x x x x x x
Diameter

7 x x x x x x
(mm]

8 x x x x x
9 x x x x
10 x x x x

STORAGE CONDTIONS

Store in a cool and dry place, away from direct sunlight

Storage temperature: between 0ºC and 40ºC

HT SPN BC35 ed 5 October 8th 2017 Paage 2 of 2