Solitaire FR Brochure - Intl

Clinical Education
Comprehensive Stroke Portfolio
Acute Ischemic Stroke Program
STROKE CENTERS OF EXCELLENCE PROGRAM
We believe in answering the needs of healthcare professionals involved in
revascularization by building peer-to-peer networks.
Our goal is to develop meaningful opportunities in sharing best practices
through our renowned Stroke Centers of Excellence and to build interactions
between stroke units around the world.
This program is run in partnership with world class European stroke centers
using the most advanced tools, protocols and techniques. The faculty includes
world-renowned neurologists and interventional neuroradiologists from:
• Karolinska Institute, Stockholm, Sweden
• Inselspital, Bern, Switzerland
• Gui-de-Chauliac, Montpellier, France
Course Education
Objectives
Solitaire™ FR Revascularization Device
• Considerations for
Organizing a Stroke
Team and a Stroke Unit
• Develop Acute Ischemic
Stroke Protocols
• Discuss Acute Ischemic
Stroke Treatment
Evolution and Status
Recommended
Vessel Diameter
(mm)
Minimum
Micro Catheter
ID (in)
Push Wire
Length
(cm)
Diameter
(mm)
Usable
Length
(mm)
Total
Length
(mm)
Distal
Markers
Proximal
Markers
SFR-4-15
2.0 – 4.0
0.021
180
4
15
26
3
1
SFR-4-20
2.0 – 4.0
0.021
180
4
20
31
3
1
SFR-6-20
3.0 – 5.5
0.027
180
6
20
31
4
1
Solitaire™ FR Device Stroke Kit 4x15
SFR-6-30
3.0 – 5.5
0.027
180
6
30
42
4
1
Solitaire™ FR device 4mm x 15mm
Cello™ 8F balloon guide catheter8
Rebar™ 18 micro catheter
Cello™ Balloon Guide Catheter
• Improve Patient
Selection and
Treatment Parameters
Catalog
Number
Product Name
Conformable
Sheath (F)
Tip Length
(mm)
Balloon
Length (mm)
ID (mm)
Effective
Length (cm)
Total
Length
(cm)
1610060
Cello 6F+
7
3
7
1.30 (0.051 in)
102
110
1610070
Cello 7F+
8
3
7
1.75 (0.069 in)
102
110
1610080
Cello 8F
8
3
10
1.90 (0.075 in)
95
102
1610090
Cello 9F
9
3
10
2.15 (0.085 in)
92
100
Rebar™ 18 Reinforced Micro Catheter
*Dual Marker Band.
Catalog
Number (1/box)
OD (F)
Distal ID (in)
Total Length
(cm)
Usable Length
(cm)
Max.
Guidewire (in)
105-5081-153 *C
2.8-2.3
0.021
153
153
0.018
105-5081-130
2.8-2.3
0.021
135
130
0.018
105-5083-153
2.8-2.3
0.021
158
153
0.018
• Case Reviews and
Complications
Rebar™ 27 Reinforced Micro Catheter
• Hands-on Experience
Catalog
Number (1/box)
OD (F)
Distal ID (in)
Total Length
(cm)
Usable Length
(cm)
Max.
Guidewire (in)
105-5082-130
2.8-2.8
0.027
135
130
0.018
105-5082-145
2.82.8
0.027
150
145
0.018
Solitaire™ FR DEVICE Offers
Optimized Outcomes
•
•
•
•
Solitaire™ FR
Device Stroke Kit
Configurations
Catalog
Number
Easy-to-Use and Single-Operator
Short Procedure Time
Fast Flow Restoration and Reliable Clot Removal
Optimized Performance with State-of-the-Art
Covidien Products
Solitaire™ FR Device Stroke Kit 4x20
Solitaire™ FR device 4mm x 20mm
Cello™ 8F balloon guide catheter8
Rebar™ 18 micro catheter
Solitaire™ FR Device Stroke Kit 6x20
Solitaire™ FR device 6mm x 20mm
Cello™ 8F balloon guide catheter8
Rebar™ 27 micro catheter
Solitaire™ FR Device Stroke Kit 6x30
Solitaire™ FR device 6mm x 30mm
Cello™ 8F balloon guide catheter8
Rebar™ 27 micro catheter
Total Length
Solitaire™ FR
Revascularization Device
Retrieval Zone
Diameter
Push Wire
Proximal Marker
Distal Markers
Availability of product may vary by region. Please contact your Covidien sales representative regarding availability in your country.
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+33 156 88 59 10 [t]
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www.covidien.com
• Clinical Studies
• Clinical Education
• Comprehensive Stroke Portfolio
Clinical Studies
Solitaire™ FR Revascularization Device
RADIAL FORCE 3
Restore Flow
Deployment
Radial Force (N/mm)
0.08
Unique design.
Fast flow restoration.
FAST FLOW RESTORATION
Retrieval
Solitaire™ FR With Intention
For Thrombectomy (SWIFT)7
Retrospective
Study7
J.L. Saver, U.S.A.
N/A
113
(58 Solitaire™ FR, 55 MERCI™*)
141
200
(enrolling)
17.3
18
(8-30)
68.5%
-
N/A
-
85%
Primary Endpoint
mRS≤2 at 90 days
36.3%
54.6%
Secondary Endpoint
Mortality at 90 days
17.2%
20.5%
N/A
Device Related Adverse Events
8.6%
0.7%
N/A
SICH6
1.7%
4%
N/A
0.06
0.04
Principal Investigators (PI)
0.02
The Solitaire™ FR device’s self-expanding
design creates a simple, single-operator
1
procedure.
0
0.71
1
1.5
2
2.5
3
3.5
Number of Patients
4
Constrained Diameter (mm)
Based on an average of N=3 4x20 Solitaire™ FR Revascularization Devices
Maximized radial force when deployed within
occlusion to facilitate fast flow restoration.
Baseline NIHSS
Flow restoration to the MCA upon deployment of
the Solitaire™ FR device.
Recanalization Rate
(TIMI≥2)
Revascularization Rate
(TICI≥2b)
VESSEL WALL
CELL AREA 3
0.12
Retrieve Clot
2
Clot
0.08
0.095mm
0.1115mm2
0.06
0.04
2.25mm2
0.0
Depiction of a 4x20 Solitaire FR Device in a vessel.
Revive
Cell Area in Constrained Tube.
Parametric™ Design preserves cell-size over
varying vessel diameters which enhances clot
capture and retrieval.
Neurological Outcomes
Revascularization Rate
Solitaire™ FR Thrombectomy for Acute Revascularization (STAR): The purpose of this study is to evaluate the safety and efficacy of the Solitaire™
FR device in subjects requiring mechanical thrombectomy when used to its Instructions For Use (IFU), in real life practice.
3.0mm2
Based on an average of N=2 4x20 Solitaire™ FR Revascularization Devices.
™
Solitaire™ FR Revascularization
Device in a 3mm Vessel.
An optimal balance of navigability, wall-apposition,
and clot retention.
REFERENCES
1. Design Specification: PS08-001F. 2. Covidien Testing Data: FD2601A. 3. FD2815: Competitive Device Test Plan---Flow Restoration Device. 4. SolitaireTM FR Retrospective Study 5. The Solitaire™ FR
Revascularization Device is superior to the Merci Retrieval System™* in achieving arterial recanalization of the occluded target vessel without any presence of symptomatic intracranial hemorrhage in the
Solitaire™ FR With Intention For Thrombectomy (SWIFT) Study SWIFT IDE # GO90082 FD2923. 6. Symptomatic Intracerebral Hemorrhage 7. Corelab reviewed 8. The CelloTM balloon guide catheter may not
be available for distribution in your country.
Mortality Rate
INITIAL ANGIOGRAM
4
J. Gralla, Switzerland
Retrospective Study: The purpose of this study is to provide safety and efficacy data on the Solitaire™ FR device when used as a first choice device in
real practice in revascularization of patients with acute ischemic stroke.
0.02
V E SS E L WA LL
V. Mendes Pereira, Switzerland
Solitaire™ FR With Intention For Thrombectomy (SWIFT): The purpose of this study is to demonstrate substantial equivalence of the Solitaire™ FR
revascularization device with a legally marketed device, Merci Retrieval System™*.
mm2
Solitaire™ FR
Device deployed
Solitaire™ FR device with Parametric™
Design provides multiple planes of
clot contact to enhance capture.2
AFTER INITIAL DEPLOYMENT
96.0%
68.5%
Next generation technology.
Revolutionary clinical results.
Solitaire™ FR revascularization device is the
most effective5 mechanical thrombectomy
device combining the ability to immediately
restore blood flow, administer medical
therapy and retrieve clot in patients
experiencing acute ischemic stroke.
81% of Area Maintained
0.1
Maximize clot retrieval.
Minimize procedure time.
Neurological Tissue
WALL APPOSITION 3
Solitaire™ FR Thrombectomy for Acute
Revascularization (STAR)7
58.2%
54.6%
20.5%
36.0%
Retrospective Study (TICI≥2a)
SWIFT (TIMI≥2)
Retrospective Study
(mRS≤2)
SWIFT
(mRS≤2)
SWIFT
(Good Neurological
Outcomes)
Good neurological outcome defined as mRS ≤ 2, or equal to the prestroke
mRS if the prestroke mRS was higher than 2, or NI HSS score improvement
of 10 points or more.
Retrospective Study
17.2%
For general inquiries or to learn more about
Physician Workshops and Centers of Excellence,
please email [email protected]
SWIFT
Case study images provided with permission by Prof. Andersson, Karolinska Hospital, Helsinki, Sweden.