solitaire fr brochure
TRANSCRIPT
NEUROVASCULAR | PERIPHERAL VASCULAR Access · Balloons · Carotid · Embolic Coils · Embolic Protection · Flow Diversion · Flow Restoration · Liquid Embolics · Plaque Excision · Procedural Support · Remodeling Devices · Retrieval Devices · Stents
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World Headquarters
Peripheral Vascular
3033 Campus DrivePlymouth, MN 55441USAPH +1 763 398 7000FX +1 763 398 7001
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Distribution Centre
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ev3 Technologies
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www.ev3.net Find out more at ev3.net
Introducer Sheath
Total Length
Push Wire
Proximal MarkerDistal Markers Retrieval Zone
Usable Length*
Distal and proximal markers
ensure that the entire usable
length of the Solitaire FR
device extends past both
ends of the thrombus.
*Positioning
Right Carotid angiogram. Lateral view. Solitaire FR deployed.
Proximal Marker Band
Distal Marker Bands
Restore. Retrieve.
Revive.
Solitaire™
FRRevascularization
Device
Indication, contraindication, warnings and instructions for use can be found in the product labeling supplied with each device.
Solitaire FR Revascularization Device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion.Patients who are ineligible for intravenous tissue plasminogen activator, IV t-PA, or who fail IV t-PA therapy are candidates for treatment.
Solitaire and Rebar are trademarks of ev3 Inc.
©2009 ev3 Inc. All rights reserved. 75677-001 (A) OCT/09 – Intl.
Device Details
* Dual Marker Band.
Balloon guide catheter sold separately.
ReferenceNumber
Size (mm)
Usable Length (mm)* Total Length (mm)
2 3 4 5 5.5
Vessel Diameter (mm) Vessel Diameter (mm)
Solitaire™ FR Device Selection
15.6
20.6
22.5
34.6
–
–
19.6
30.9
4 x 15
4 x 20
6 x 20
6 x 30
SRD-4-15
SRD-4-20
SRD-6-20
SRD-6-30
20.3
26.3
_
–
17.6
22.5
24.8
37.3
–
–
18.7
29.4
2 3 4 5 5.5
27.3
32.1
33.8
45.7
–
–
32.7
43.9
29.5
35.2
_
–
27.7
33.1
35.1
47.9
–
–
32.4
43.2
2.0 – 4.0
2.0 – 4.0
3.0 – 5.5
3.0 – 5.5
Recommended Vessel
Diameter (mm) ReferenceNumber
Size(mm)
Solitaire™ FR Revascularization Device Ordering Information
4 x 15
4 x 20
6 x 20
6 x 30
SRD-4-15
SRD-4-20
SRD-6-20
SRD-6-30
2.0 – 4.0
2.0 – 4.0
3.0 – 5.5
3.0 – 5.5
Push WireLength (cm)
180
180
180
180
0.021
0.021
0.027
0.027
MinimumMicrocather ID (in)
3
3
4
4
DistalMarkers
1
1
1
1
ProximalMarkers
ReferenceNumber
Catheter Class
Usable Length(mm)
18
18
27
27
105-5081-153*
105-5083-153
105-5082-130
105-5082-145
153
153
130
145
0.021
0.021
0.027
0.027
MinimumGuidewire ID (in)
0.018
0.018
0.018
0.018
MaximumGuidewire ID (in)
2.7F
2.7F
2.8F
2.8F
ProximalOD
DistalOD
2.4F
2.4F
2.8F
2.8F
RecommendedVessel
Diameter (mm)
Rebar™ Microcatheter Ordering Information
Your endovascular company.™www.ev3.net
Immediate flow restoration upon deployment
Administration of medical therapy
Clot retrieval
Solitaire™ FR Revascularization Device is the only mechanical thrombectomy device combining the ability to immediately restore blood flow, administer medical therapy, and retrieve clot in patients experiencing acute ischemic stroke.
* Data on file.
Immediate Flow Restoration
Effortless delivery
Swift deployment for fast reperfusion
Optimal radial force for all clot types
Multiple Mechanisms of Action
Temporary bypass of occluded vessel
Stable recanalization for the adjunctive
use of medical therapy
Optimal metal to tissue ratio for reliable
clot retrieval
High Rates of Recanalization*
Potential for improved patient outcomes
Efficacious clot removal in vessels sized
2 to 5.5 mm
Figure 1.
Distal M1 OcclusionFigure 2.
Deployment – 10mg rtPA
Figure 3.
Injected progressively 15mg of rtPA
Figure 4.
Final TICI 2b
1 2
3 4
Figure 1.
Carotid T thrombusFigure 2.
Pass 1 – TICI1
Figure 3.
Pass 1 – TICI1
Figure 5.
Final control – TICI 3
Figure 4.
Pass 2 – TICI 2A
Figure 6.
Final control – TICI 3
1 2
3
5
4
6
Vitor Mendes Pereira, Ana Paula Narata, Hasan Yilmaz,
Jean Baptiste Martin, Roman Sztajzel, Karl-Olof Lovblad
Geneva Stroke Center
Case DescriptionMale, 66 years old patientChronic atrial fibrillationRight hemiparesia and aphasiaBaseline NIHSS 14
Results3 month follow-up
– NIHSS 3 – mRS 1
Case DescriptionMale, 48 years old patientPatent foramen ovaleLeft hemiparesis, NIHSS 12Presented 2h post-onsetFailed EV Thrombolysis (0.6mg/kg in 30 minutes)Solitaire FR first line device2 passes with combined IA rtPA – First pass 5mg – Second pass 10mg– Total 15mg deliveredFinal post-procedure TICI 3
Results3 month follow-up
– NIHSS 0 – mRS 0
Vitor Mendes Pereira, Ana Paula Narata, Hasan Yilmaz,
Jean Baptiste Martin, Roman Sztajzel, Karl-Olof Lovblad
Geneva Stroke Center
Optimal Navigability
Consistent performance in distal
and proximal locations
Balanced design to optimize deliverability
and radial force
Electro-polished surface for easy
pushability
One-step Deployment
Single-operator delivery and deployment
Ease of use offers enhanced procedural
control with maximum accuracy of
deployment
Easy deployment offers the potential for
immediate flow restoration for added time
and control
3° of Freedom for Maximum Stability and Clot Retrieval
Unique overlap allows for near
preservation of stent cell size through
varying vessel calibers during clot
retrieval
Stable cell design enables the clot to
embed into individual struts for maximum
clot retention
Effective in engaging both soft and firm
clot due to the cellular design
Case Studies When Every Second Counts
Case 1
Immediate Flow Restoration with the Administration of Lytics
Case 2
Thrombectomy Using the Solitaire FR Revascularization Device