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English 1
Stealth 360™ GEN2 Peripheral Orbital Atherectomy System
Instructions for use
Including the Orbital Atherectomy Device with GlideAssist
®
, Saline Pump, ViperWire Advance
®
Peripheral
Guide Wire, and
ViperWire Advance ®
with FlexTip Peripheral Guide Wire
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
The following are trademarks of Cardiovascular Systems, Inc.: CSI
®
, Stealth 360
®
, ViperWire
®
, ViperWire
Advance
®
, ViperSlide
®
, GlideAssist
®
Explanation of symbols on package labels
Refer to the package labels to see which symbols
apply to specific products.
Lot number
Model number
Consult IFU
www.csi360.com (USA)
(symbol appears in blue
when placed on the
device itself)
Caution: Consult IFU
www.csi360.com (USA)
Do not reuse
Do Not Resterilize
Sterilized with Ethylene
Oxide
Manufacturer
Use by
Maximum guide wire tip
diameter
Maximum guide wire
shaft diameter
Guide wire length
Caution: Federal Law
(USA) restricts this device
to sale by or on the order
of a physician.
Contains Phthalates
1. System description
The Stealth 360
®
Peripheral Orbital Atherectomy
System is a minimally invasive percutaneous
orbital atherectomy system (OAS). It is designed
for improving luminal diameter in patients with
peripheral arterial disease (PAD). PAD is caused
by the accumulation of plaque in the arteries of the
leg or foot and reduces blood flow that may lead
to pain, tissue loss, and eventual foot amputation,
leg amputation or death. This system treats a
broad range of plaque types in the lower limbs
and reduces or removes occlusive material by
using a spinning, orbiting diamond-coated crown,
within peripheral arteries, in order to restore lumen
patency.
The OAS consists of:
• Hand-held Stealth 360
®
Peripheral Orbital
Atherectomy Device (OAD)
• Saline Pump (OAS pump)
•
ViperWire Advance ®
Peripheral Guide Wire
(guide wire) or CSI ViperWire Advance
®
with
FlexTip Peripheral Guide Wire (guide wire)
• CSI ViperSlide
®
Lubricant
The
Stealth 360 ®
Peripheral Orbital Atherectomy
System is indicated for use as therapy in patients
with occlusive atherosclerotic disease in peripheral
arteries and who are acceptable candidates for
percutaneous transluminal atherectomy.
2. Component Descriptions
2.1. Orbital Atherectomy Device (OAD)
Description
The OAD (Figure 1) is a hand-held component
of the OAS that provides the physician with
independent control of the OAS. The OAD is a
single use over-the-wire device consisting of a
handle, and a saline line.
The handle includes a sheath-covered drive
shaft and a diamond-coated crown. The diamond
coating on the crown provides an abrasive
surface to reduce or remove occlusive material
within peripheral arteries. The handle includes
control buttons for operating the OAD and
contains the motor and electronics that power the
rotation of the drive shaft.
Device Components:
• Crown
• Crown Advancer Knob
• Drive Shaft
• Sheath (covers the shaft proximal to the crown);
• Electrical Cord to power OAD
• Electric Motor (which spins the shaft/crown);
• Saline Port (allows for infusion of saline through
the sheath around the shaft);
• Saline Tubing (connecting the OAS pump to
the device)
Crown size determines the ability to cross the
lesion within the minimum proximal reference
vessel diameter at the treatment site. See
Table 1, Table 2, and Table 3 for available
crown sizes. See Appendices D and E for orbit
performance for the different crowns.
Table 1: Micro Crowns
Model
Number
Crown
Size
(mm)
Nose
Length*
(mm)
Shaft
Length
(mm)
PRD-SC30-MICRO
1.25 7 145
*Nose length is the length of the drive shaft from the crown to
the distal tip of the shaft.
Table 2: Solid Crowns
Model
Number
Crown
Size
(mm)
Nose
Length*
(mm)
Shaft
Length
(mm)
PRD-SC30-125
1.25 7 145
PRD-SC30-150
1.50 10 145
PRD-SC30-200
2.00 30 145
RAD-SC30-125
1.25 10 200
RAD-SC30-150
1.50 10 200
RAD-SC30-175
1.75 30 180
Table 3: Classic Crowns
Model
Number
Crown
Size
(mm)
Nose
Length*
(mm)
Shaft
Length
(mm)
DBE-150
1.50 15 145
DBE-200
2.00 20 145
Figure 1. Stealth 360
®
Orbital Atherectomy Device
A. Nose Length
B. Crown
C. Strain Relief
D. Lockable Crown Advancer Knob
E. On/Off Button
F. Crown Rotation Speed Control Buttons and
Indicators
G. Guide Wire Brake Lever
H. Electrical Power Cord
I. Device Saline Port Connector
J. Saline Bag Spike
K. Saline Tubing Positioners
L. Saline Tubing
M. Injection Port
N. Saline Line Port Connector
O. Travel Indicating Ruler
P. Saline Prime Button
Device Features:
• On/Off button on Crown Advancer Knob to
control when the crown starts and stops spinning;
• 3 Speed Control Buttons to select the crown
rotation speed;
• GlideAssist
®
to facilitate advancing and
retracting the OAD crown over the
ViperWire ®
Peripheral Guide Wire (Available on the
1.25mm Micro crown model)
• Saline Prime Button for increasing OAS pump
flow rate
• 15 cm crown advancement with travel
measurement indicators
• Guide Wire Brake to restrict both the rotational
and axial movement of the guide wire
• Drive shaft (a flexible, helically wound, stainless
steel, multiple-wire shaft that drives spinning
of the crown and allows for passage of a guide
wire)
• Eccentric Diamond-Coated crown (functions as
the abrasive surface)
• Strain Relief to prevent kinks in the sheath and
drive shaft.
2.1.1 OAD Package Contents
The OAD and accessories are supplied sterile
and are for single-use only. Each package
contains:
• OAD
• Saline Line (connects the OAD to the OAS
pump)
2.2. Crowns
A crown is a diamond-coated, abrasive surface
mounted on the driveshaft that is designed to
track and spin over the guide wire and remove
or reduce the occlusive tissue into microscopic
particles.
Select a crown size based on its ability to cross
the lesion and the minimum proximal reference
vessel diameter within the treatment area. See
Appendix B for crown sizes and selection and
Appendix D for the maximum orbit/resulting
lumen diameter for each crown.
Explanation of symbols on the Saline Pump
Low saline red LED
indicator
Start button and pump
ON green LED indicator
Pump status yellow LED
indicator
Prime button
Type CF Applied Part
Slow Blow Type T Fuse
Finger Caution
Explanation of Symbols on the Orbital
Atherectomy Device
Prime button
Low speed button
Medium speed button
High speed button
Table of Contents
1. System description ............................................1
2. Component Descriptions ...................................1
3. Indications for Use ............................................2
4. Contraindications ...............................................2
5. Restrictions ........................................................2
6. Warnings ..........................................................2
7. Precautions........................................................2
8. Adverse events .................................................2
9. Clinical Trials Summary ....................................2
10. Storage and Handling ......................................2
11. Equipment, Setup, and Test .............................3
12. OAS Directions for Use ...................................3
13. Maintaining the OAS pump..............................4
14. Specifications ..................................................4
15. OAS Pump Declaration of Conformity .............4
16. EMC Declaration ............................................5
17. Disclaimer of Warranty ....................................5
Appendix A. System Troubleshooting ....................5
Appendix B. Introducer, Guide Sheath, or
Guide Catheter Size .........................................6
Appendix C. ViperWire Advance
®
Peripheral
Guide Wire Specifications ...............................6
Appendix D. Maximum Orbit and Resulting
Lumen Diameter ..............................................6
Appendix E. Orbit Performance ............................7