Solitaire FR Brochure
2
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 ev3 Corporate World Headquarters Peripheral Vascular 3033 Campus Drive Plymouth, MN 55441 USA PH +1 763 398 7000 FX +1 763 398 7001 ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 USA PH +1 949 837 3700 FX +1 949 837 2044 ev3 International Distribution Centre Europalaan 25 6199 AB Maastricht-Airport The Netherlands PH +31 (0) 433 659 220 FX +31 (0) 43 364 6395 ev3 SAS France PH +33 (0) 156 88 31 10 FX +33 (0) 156 88 31 11 ev3 B.V. Benelux PH +31 (0) 433 659 223 FX +31 (0) 433 650 283 ev3 Technologies lberica, S.L. Spain PH +34 91 656 7154 FX +34 91 656 7214 ev3 S.r.l Italy PH +39 0267 977 61 FX +39 0266 711 637 ev3 Nordic AB PH +46 859 000 950 FX +46 859 000 959 ev3 Sp z o.o. Poland PH +48 32 747 01 44 FX +48 32 747 01 45 ev3 GmbH Germany, Austria PH +49 228 528 830 FX +49 228 528 8360 ev3 Ltd. United Kingdom PH +44 1279 659 900 FX +44 1279 654 900 ev3 Europe International Headquarters 106-108 rue La Boétie 75008 Paris France PH +33 156 88 59 10 FX +33 156 88 59 11 www.ev3.net Find out more at ev3.net Introducer Sheath Total Length Push Wire Proximal Marker Distal 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 ™ FR Revascularization 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. Reference Number 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) Reference Number 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 Wire Length (cm) 180 180 180 180 0.021 0.021 0.027 0.027 Minimum Microcather ID (in) 3 3 4 4 Distal Markers 1 1 1 1 Proximal Markers Reference Number 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 Minimum Guidewire ID (in) 0.018 0.018 0.018 0.018 Maximum Guidewire ID (in) 2.7F 2.7F 2.8F 2.8F Proximal OD Distal OD 2.4F 2.4F 2.8F 2.8F Recommended Vessel Diameter (mm) Rebar ™ Microcatheter Ordering Information Your endovascular company. ™ www.ev3.net
Transcript of Solitaire FR Brochure
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
ev3 Corporate
World Headquarters
Peripheral Vascular
3033 Campus DrivePlymouth, MN 55441USAPH +1 763 398 7000FX +1 763 398 7001
ev3 Neurovascular
9775 Toledo WayIrvine, CA 92618 USAPH +1 949 837 3700FX +1 949 837 2044
ev3 International
Distribution Centre
Europalaan 256199 AB Maastricht-AirportThe NetherlandsPH +31 (0) 433 659 220FX +31 (0) 43 364 6395
ev3 SAS France
PH +33 (0) 156 88 31 10FX +33 (0) 156 88 31 11
ev3 B.V. Benelux
PH +31 (0) 433 659 223 FX +31 (0) 433 650 283
ev3 Technologies
lberica, S.L. Spain
PH +34 91 656 7154FX +34 91 656 7214
ev3 S.r.l Italy
PH +39 0267 977 61FX +39 0266 711 637
ev3 Nordic AB
PH +46 859 000 950FX +46 859 000 959
ev3 Sp z o.o. Poland
PH +48 32 747 01 44FX +48 32 747 01 45
ev3 GmbH Germany, Austria
PH +49 228 528 830FX +49 228 528 8360
ev3 Ltd. United Kingdom
PH +44 1279 659 900FX +44 1279 654 900
ev3 Europe
International Headquarters
106-108 rue La Boétie75008 ParisFrancePH +33 156 88 59 10FX +33 156 88 59 11
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
