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

II. DEVICE DESCRIPTION/TECHNICAL DESCRIPTION
The FLEX Vessel Prep™ System™ is an over-the-wire
sheathed catheter with a three-strut treatment
element near the distal tip as shown in Figure 1.
The FLEX Vessel Prep™ System is advanced over a
0.014" or 0.018" guidewire until distal to the lesion
to be treated. The Treatment Element is unsheathed
and expanded. The Treatment Element consists of
three independent flexible struts, each with a
precision blade, mounted on the proximal end. As
the device is pulled back in a retrograde fashion
through the target lesion, the Treatment Element
"flexes" providing continuous engagement along the
lesion to create controlled-depth micro-incisions.
The Flex Vessel Prep™ catheter is available in 3
lengths, 120cm, 75cm, and 40cm. The device has a
2mm crossing profile and is compatible with 6 French
introducer sheaths. It is recommended to use a 150
cm+ guidewire with the 40cm/75cm product and a
300cm guidewire with the 120cm product.
The device consists of three integrated components.
The Control Handle, which contains a Guidewire Port
for guidewire insertion, a Flush Port to flush with
saline to remove air from the device, the Sheath
Actuator and Treatment Element Actuator.
The Sheath Actuator is located on the flat surface of
the handle below the word FLEX. When the Sheath
Actuator is pulled back and held in place, the sheath
covering the Treatment Element is retracted and the
Treatment Element is exposed. A click verifies the
sheath is fully retracted.
The Treatment Element Actuator is located on the
curved aspect of the handle, above the word FLEX.
When the Treatment Element Actuator is pulled back
and held in place, the Treatment Element expands
the 3 flexible struts of the Treatment Element.
The Reinforced Braided Shaft, which is enclosed
within a clear polymer sheath, provides strength to
enhance deliverability and torque performance of
the device.
100073 Revision R
The distal end of the device contains a radiopaque
marker to aid in positioning the catheter and the
Treatment Element.
The Treatment Element as shown in Figure 2 consists
of three precision blades, 10 thousandths of an inch
(0.010") in height and mounted on the proximal end
of each of the three independent flexible struts. The
expansion of the Treatment Element allows the three
precision blades to independently engage the lesion.
During the retrograde pull-back of the device, each
strut of the protective Treatment Element "flexes"
independently to provide continuous engagement
along and through complex lesions to create
controlled-depth micro-incisions along the length of
the lesion. These micro-incisions modify the plaque
in the lesion and enable dilatation of the target lesion
using percutaneous angioplasty balloons at lower
inflation pressures, minimizing barotrauma to the
vessel.
Date of Issue: 2022-06
Figure 2
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