2
English
2.3. OAS Pump Description
The OAS pump provides the saline/lubricant
pumping mechanism and power to the device.
The small, reusable, and portable OAS pump
attaches to a standard five-wheel rolling
intravenous (IV) pole (Figure 2 and 3) and plugs
in to a wall power outlet. The OAS pump includes
a built-in, audible 25 second spin time notification,
system power and priming buttons, and status
indicators.
OAS Pump Model Number: SIP-3000
Figure 2.
OAS Pump Front View
A. IV pole screw clamp
B. IV pole (not included)
C. Low saline level sensor and connector cord
D. Control panel
E. OAS Pump door
F. OAD connection
Figure 3.
OAS Pump Rear View
A. Master Power Switch
B. AC Power Cord Input
C. Saline Sensor Jack
2.3.1 OAS Pump Package Contents
The OAS pump and accessories are supplied
non-sterile. Each package contains:
• OAS Pump (with attached IV pole screw
clamp)
• Power Cord
• Low Saline Level Sensor and Connector Cord
2.4.
ViperWire Advance
®
Peripheral Guide
Wire Description
The
ViperWire Advance
®
Peripheral Guide Wires
(Table 4) and
ViperWire Advance
®
with FlexTip
Peripheral Guide Wires (Table 5) are smooth,
stainless steel wires, with a silicone coating, and
a radiopaque distal spring tip The Guide Wires
(Figure 4) allow for proper positioning of the OAD
crown within peripheral arteries and provides a
center of rotation for the OAD drive shaft. The
Guide Wire Torquer is a small, plastic accessory,
packaged with the guide wire, and provides a
gripping surface for manipulating the guide wire.
Guide Wires are available in a variety of spring tip
diameters (Appendix C).
Warning:
The device is designed to track and
spin only over the CSI ViperWire Advance
®
Peripheral Guide Wire or the ViperWire Advance
®
with
FlexTip
Peripheral Guide Wire. Do not use
any other guide wire with this device.
Table 4:
ViperWire Advance
®
Peripheral Guide
Wires
Model
Number
OAD Device
Shaft Length
Compatibility
Guide wire
Spring Tip
Diameter
Guide
Wire
Length
VPR-GW-14
145 cm
0.014"
335 cm
VPR-GW-17
145 cm
0.017"
335 cm
VPR-GW-EL14
180 and 200 cm
0.014"
475 cm
VPR-GW-EL18
180 and 200 cm
0.018"
475 cm
Table 5:
ViperWire Advance
®
with FlexTip
Peripheral Guide Wire
Model
Number
OAD Device
Shaft Length
Compatibility
Guide wire
Spring Tip
Diameter
Guide
Wire
Length
VPR-GW-FLEX14
145 cm
0.014"
335 cm
VPR-GW-FLEX18
145 cm
0.018"
335 cm
Figure 4.
Guide Wire
A. Distal spring tip
2.4.1
ViperWire Advance
®
Peripheral Guide
Wire Package Contents
The guide wire and guide wire torquer are
packaged separately from the OAD, and
are supplied sterile for single-use only. Each
ViperWire Advance
®
package contains:
• Five (5) Guide Wires
• Five (5) Torquers
2.5.
ViperSlide
®
Lubricant Description
ViperSlide
®
Lubricant reduces friction between
the OAD drive shaft and the
ViperWire
®
Peripheral Guide Wire. Flowing saline and
lubricant solution is required for cooling and
lubricating the OAD during use to avoid
overheating and permanent damage to the
OAD and possible patient injury.
ViperSlide
®
is
packaged separately from the OAD.
Note: Please refer to the ViperSlide
®
Lubricant
IFU for indications, contraindications, warnings
and precautions prior to starting the atherectomy
procedure.
ViperSlide
®
Lubricant Model Number:
VPR-SLD2
3. Indications for Use
The
Stealth 360
®
Peripheral Orbital Atherectomy
System is a percutaneous orbital atherectomy
system indicated for use as therapy in patients
with occlusive atherosclerotic disease in peripheral
arteries and who are acceptable candidates for
percutaneous transluminal atherectomy.
4. Contraindications
Use of the OAS is contraindicated for use in the
coronary arteries and in the following situations:
• The
ViperWire
®
peripheral guide wire cannot be
passed across the peripheral lesion.
• The target lesion is within a bypass graft or stent.
• The patient has angiographic evidence of
thrombus; thrombolytic therapy must be instituted
prior to atherectomy.
• The patient has angiographic evidence of
significant dissection at the treatment site. The
patient may be treated conservatively to permit
the dissection to heal before treating the lesion
with the OAS.
5. Restrictions
Federal Law restricts the use of this system to
physicians who are experienced in peripheral
angioplasty at their institutions and trained on the
use of the OAS. Contact a CSI representative for
information on training.
6. Warnings
• Do
not
use the OAD in a vessel that is too small
for the crown. The reference vessel diameter at
the treatment area must be at least 2.00 mm in
diameter for the 1.25mm Micro crown.
• If mechanical failure of the OAD occurs before or
during the atherectomy procedure, discontinue
use immediately. Do not attempt to use a
damaged OAD or other system component. Use
of damaged components may result in system
malfunction or patient injury.
• Do
not
use the OAD during spasm of the vessel.
• Only use approved and compatible
ViperWire
Advance
®
peripheral guide wires. See Appendix
C for the appropriate guide wire to use based
on the OAD shaft configuration. Follow CSI’s
instructions related to guide wire use.
• Do
not
continue treatment if the guide wire or the
OAD becomes sub-intimal.
• Immediately stop spinning device if the OAD
stalls. Review for complications and mechanical
failure if a stall condition occurs. Do not change to
a higher speed if the OAD stalls.
Note:
If a stall occurs, the
On/Off
button is
inactive for five seconds. If the On/Off button is
pressed during this five second lockout period,
the lockout period will begin again.
• Performing treatment in vessels or bifurcations
that are excessively tortuous or angulated may
result in vessel damage.
•
Always use fluoroscopy when advancing the
guide wire to avoid misplacement, dissection, or
perforation. The OAD tracks over the guide wire,
so it is imperative that the guide wire be initially
placed through the stenotic lumen and not in a
false channel.
• Do
not
inject contrast while OAD crown is
spinning. OAD failure or patient harm may occur.
• Do
not
attempt aspiration through the OAD or
saline line while placed within the body. If saline is
pulled out through the OAD or saline line, air may
enter the system.
• If air is noticed in the system while the OAD is
within the body, discontinue treatment by pressing
the OAS Pump power button and carefully
remove the OAD driveshaft and crown from the
introducer sheath/guide catheter.
• Handle the OAD and guide wire carefully. A tight
loop, kink, or bend in the guide wire may cause
damage and system malfunction during use.
• Never operate the OAD without normal saline and
lubricant solution. Flowing saline and lubricant
solution is required for cooling and lubricating
the OAD during use to avoid overheating and
permanent damage to the OAD and possible
patient injury.
• The crown at the distal tip of the OAD operates
at very high speeds. Do not allow body parts
or clothing to come into contact with the crown.
Physical injury or entanglement may occur.
• Never advance the orbiting crown to the point
of contact with the guide wire spring tip. Distal
spring tip detachment and embolization may
result. Make sure there is a minimum of 10 cm
between the guide wire spring tip and the distal
end of the shaft.
• Always advance the orbiting abrasive crown by
using the crown advancer knob. Never advance
the crown by advancing the drive shaft or OAD
handle. Guide wire buckling may occur, and
perforation or vascular trauma may result.
• Always keep the crown advancing or retracting
while it is at high rotational speeds. Do not allow
the crown to remain in one location for more
than 2–3 seconds. Maintaining the crown in one
location while it is orbiting at high speeds may
lead to excessive tissue removal.
• Do
not
start or stop orbiting of the crown when in
a tight lesion.
• Never force the crown when rotational or
translational resistance occurs; vessel perforation
may occur. If resistance to motion is noted, retract
the crown and stop treatment immediately. Use
fluoroscopy to analyze the situation.
• When treating tight stenosis, create a channel at
low or medium speed before traversing the lesion
at high speed. Crossing a tight stenosis on high
speed may cause the shaft and/or guide wire to
fracture as a result of excessive force.
• While advancing the crown through the introducer
sheath/guide catheter, do not activate crown
rotation. The crown must not spin while located
within the introducer sheath/guide catheter.
• The maximum travel of the crown advancer
knob—and therefore the shaft tip—is 15 cm.
Moving the crown advancer knob forward moves
the shaft tip an equal distance toward the guide
wire spring tip. Use contrast injections and
fluoroscopy to monitor movement of the shaft tip
in relation to the guide wire spring tip.
• Do
not
prolapse or bend the guide wire core. If
the spring tip becomes prolapsed, keep the bend/
prolapse contained within the spring tip section
only. Spinning over a prolapsed or bent guide
wire core can result in damage to the guide wire
or OAD.
• The system should not be used on children or
pregnant women.
• Do
not
re-use or re-sterilize the OAD. If the OAD
is re-used, the OAD may not function as intended
and serious infection, leading to potential harm
and/or death, may occur.
• Do not spin the crown in
GlideAssist
®
mode
with the guide wire brake lever in the unlocked
position, without first securing the guide wire
by holding it with fingers or with the guide wire
torquer. If using the guide wire torquer, ensure
that it is securely fastened to the guide wire
before starting to spin the crown. Failure to
secure the guide wire when the brake is unlocked
could allow the guide wire to spin and/or Migrate
while in
GlideAssist
®
mode which may result in
patient harm.
7. Precautions
• Do not use the product if the sterile packaging
appears damaged or the shelf life has expired.
•
Do not flip contents of trays into the sterile field
as damage may occur. Components within trays
must be carefully removed and placed into sterile
field to avoid damage.
• Follow standard hospital atherectomy policies
and procedures, including those related to
anticoagulation and vasodilator therapy.
•
Radiographic equipment for fluoroscopy should
be used to provide high-resolution images. Guide
wires and catheters should only be manipulated
under fluoroscopy.
• Because of the torque responsiveness of
ViperWire
®
Guide Wires, they are more difficult to
handle than other commercially available guide
wires used in peripheral angioplasty. Exercise
care when using these guide wires.
• Use only normal saline and lubricant solution
as the infusate. (Drugs such as vasodilators
are added to the infusate at the physician’s
discretion). The OAD may malfunction if contrast
or other substances are injected into the OAD
infusion port.
• Do
not
operate the OAD without using
recommended lubricant concentration (maximum
speeds may not be achieved without lubricants).
• Ensure the OAD strain relief remains straight
during atherectomy treatment.
• To relieve compression in the driveshaft, lock
the crown advancer knob at 1cm from the full
back position, advance device over the wire to a
position proximal from the lesion, deploy the guide
wire brake, then unlock the crown advancer knob
and move it fully proximal. If the OAD is started
with existing compression in the driveshaft, it may
result in the crown springing forward.
• If 1:1 motion is not observed between the crown
advancer knob and the crown, retract and
re-advance the crown into the lesion. Repeat
retracting and advancing the crown into the lesion
until 1:1 movement is observed. If the knob and
the crown are not moving together, the crown
may be driven into the lesion with too much force
and may result in the crown springing forward on
exiting the lesion.
• When moving the crown back and forth across
the lesion, employ a series of intermittent
treatment intervals.
• Rest periods are recommended after 30-second
treatment intervals, with a maximum total
treatment time of 8 minutes.
•
Monitor the saline fluid level during the procedure.
Normal saline and lubricant solution infusion is
critical to OAD performance.
◦
Do not kink or crush the saline tubing. Flow of
saline will be reduced.
◦
Check the saline tubing and connections for
leaks during the procedure.
•
Do not allow fluid to leak onto electrical
connections of the OAS pump.
8. Adverse events
Potential adverse events that may occur and/or
require intervention as a result of the use of this
device include, but are not limited to:
• Allergic reaction to medication/media/OAD
components
• Amputation
• Anemia
• Aneurysm
• Bleeding complications which may require
transfusion
• Cerebrovascular accident (CVA)
• Death
• Distal embolization
• Entry site complications
• Hemolysis
• Hypotension/hypertension
• Infection
• Myocardial infarction
• Pain
• Pseudoaneurysm
• Restenosis of treated segment that may require
revascularization
•
Renal insufficiency/failure
•
Slow flow or no reflow phenomenon
• Thrombus
• Vessel closure, abrupt
• Vessel injury, including dissection and perforation
that may require surgical repair
• Vessel spasm
• Vessel occlusion
9. Clinical Trials Summary
See
information.
10. Storage and Handling
10.1. Storage
Store all system components at room temperature
and in a clean environment.
Do not store
ViperSlide
®
Lubricant above 25°C
(77°F). Do not freeze
ViperSlide
Lubricant. Refer
to the
ViperSlide
Lubricant IFU prior to starting
the atherectomy procedure.
10.2. Handling
• All system components are intended to be
used in typical operating room/catheterization
laboratory environments.
• Additional components should be on hand in the
event of damage to any of the components or to
component packaging.
• Do not reuse or re-sterilize the OAD Handle,
Guide Wire, Guide Wire Torquer, or lubricant as
these components are designed for single-use
only.
• Do not use the OAD, handle, or the guide wire if
their sterile package barriers are compromised
or damaged.
• Do not use the OAD, or OAS pump if any of
them were dropped onto a hard surface, from a
height at or greater than 12 in (30 cm), as these
components may be damaged and may fail to
operate properly.