Flex Vessel Prep FSC 4-120 Mode D'emploi page 7

13. The Treatment Element Actuator is retracted
and held in place to allow for expansion of the
Treatment Element. This allows the three
Precision Blades mounted on Protective
Struts to contact the vessel segment to create
micro-incisions. More pronounced deflection
of the Treatment Element Actuator towards
the back of the Control Handle allows for a
larger diameter of the Treatment Element.
Relaxation or forward deflection towards the
front of the Control Handle allows for a
smaller Treatment Element.
Caution: To minimize lateral wall pressure
and shear forces on the inner surface of
the vessel, use the smallest amount of
force necessary to allow for contact of the
Precision Blades with the vessel.
14. The device is slowly pulled back over the 0.018"
guidewire, or 0.014" guidewire in a retrograde
manner (~1-2mm/s). The Treatment Element
Actuator controls the diameter of the
Treatment Element. The appropriate diameter
allows contact with the vessel wall, which can
also be determined by the fluoroscopic image
of the Treatment Element diameter relative to
the native vessel diameter. The Treatment
Element diameter adjusts as the device is
pulled back.
Note: During pullback, the Treatment Element
may be seen flexing to accommodate the
morphology of the stenosis. It is important to
continue to hold both Actuators in place during
the pullback and maintain visual verification
that the Treatment Element remains free of the
radiopaque marker. Otherwise, it is possible
for the Sheath to recapture the Treatment
Element preventing its expansion.
Caution: If the device is not able to be pulled
back, the Treatment Element Actuator should
be pushed forward to minimize the
Treatment Element diameter through that
segment of the vessel. Advancing the Sheath
Actuator towards the front of the Control
Handle also can recapture the Treatment
Element.
100073 Revision R
15. When the desired length of the diseased vessel
16. The Sheath Actuator is unlocked by pushing it
17. Based on the clinical judgment of the
18. The FLEX Vessel Prep™ System is then removed
19. Following completion of the procedures,
20. The length of the vessel that underwent the
21. At the discretion of the operator, adjunct
Date of Issue: 2022-06
has been incised, the Treatment Element
Actuator is pushed forward/released which
allows the Treatment Element to decrease in
size to attain its smallest diameter.
forward to capture and re-sheath the
Treatment Element.
interventionalists, the device can once again be
advanced distal to the area to be treated. The
Control Handle can be rotated 30-90 degrees
and steps 12 through 16 can be repeated a
second time for a total of six longitudinal micro-
incisions, respectively.
by first re-sheathing the Treatment Element,
then withdrawing the catheter back through
the Introducer Sheath over the Guidewire,
which is left in place.
angiography is performed to document vessel
patency, luminal gain and absence
perforation, thrombosis, or embolization.
FLEX Vessel Preparation
ready for subsequent treatment at the
discretion of the operator.
therapy to maintain adequate luminal gain can
be used (PTA, stent).
calibrated to the lesion length and reference
vessel diameter and used in accordance with its
approved instructions for use.
Page 7 of 8
of
TM procedure is then
Selection should be