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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