Solitaire FR Device Selection

Reference Number Size (mm) Recommended Vessel Diameter (mm)

2 3

Solitaire FR Revascularization Device Ordering Information

Usable Length (mm)*
Vessel Diameter (mm) 4 5 5.5 2 3

Solitaire FR

Total Length (mm)

Vessel Diameter (mm) 4 5 5.5

Reference Number SRD-4-15

Size (mm) 4 x 15 4 x 20 6 x 20 6 x 30

Recommended Vessel Diameter (mm) 2.0 4.0 2.0 4.0 3.0 5.5 3.0 5.5

Push Wire Length (cm) 180 180 180 180

Minimum Microcather ID (in) 0.021 0.021 0.027 0.027

Distal Markers 3 3 4 4

Proximal Markers 1 1 1 1

Revascularization Device

SRD-4-15

4 x 15

2.0 4.0

20.3

17.6

15.6

29.5

27.7

27.3

SRD-4-20

4 x 20

2.0 4.0

26.3

22.5

20.6

35.2

33.1

32.1

SRD-4-20
SRD-6-20 6 x 20 3.0 5.5 _ 24.8 22.5 19.6 18.7 _ 35.1 33.8 32.7 32.4

SRD-6-30

6 x 30

3.0 5.5

37.3

34.6

30.9

29.4

47.9

45.7

43.9

43.2

SRD-6-20 SRD-6-30

Device Details
Total Length Usable Length*

Rebar Microcatheter Ordering Information

Reference Number Catheter Class Usable Length (mm) Minimum Guidewire ID (in) Maximum Guidewire ID (in) Proximal OD 2.7F 2.7F 2.8F 2.8F Distal OD

105-5081-153* 105-5083-153 105-5082-130 105-5082-145

18 18 27 27

153 153 130 145

0.021 0.021 0.027 0.027

0.018 0.018 0.018 0.018

2.4F 2.4F 2.8F 2.8F

Push Wire Introducer Sheath Distal Markers Retrieval Zone Proximal Marker

*Dual Marker Band. Balloon guide catheter sold separately.

Restore. Retrieve.

Revive.

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 ow 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.

Positioning
Distal and proximal markers ensure that the entire usable length of the Solitaire FR device extends past both ends of the thrombus.
Distal Marker Bands Proximal Marker Band

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 Europe International Headquarters 106-108 rue La Botie 75008 Paris France PH +33 156 88 59 10 FX +33 156 88 59 11 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 32747 01 44 FX +48 32747 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

Right Carotid angiogram. Lateral view. Solitaire FR deployed.

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Case Studies

When Every Second Counts

Optimal Navigability
Consistent performance in distal and proximal locations Balanced design to optimize deliverability and radial force Electro-polished surface for easy pushability

Solitaire FR Revascularization Device is the only mechanical thrombectomy device combining the ability to immediately restore blood ow, administer medical therapy, and retrieve clot in patients experiencing acute ischemic stroke.

Case 1 Immediate Flow Restoration with the Administration of Lytics

Vitor Mendes Pereira, Ana Paula Narata, Hasan Yilmaz, Jean Baptiste Martin, Roman Sztajzel, Karl-Olof Lovblad Geneva Stroke Center
1 2

Case Description
Male, 66 years old patient Chronic atrial brillation Right hemiparesia and aphasia Baseline NIHSS 14

Figure 1. Distal M1 Occlusion

Figure 2. Deployment 10mg rtPA

Results

Immediate Flow Restoration

Effortless delivery Swift deployment for fast reperfusion Optimal radial force for all clot types

3 month follow-up NIHSS 3 mRS 1

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

Figure 3. Injected progressively 15mg of rtPA

Figure 4. Final TICI 2b

Immediate ow restoration upon deployment

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

Case 2 Thrombectomy Using the Solitaire FR Revascularization Device

Vitor Mendes Pereira, Ana Paula Narata, Hasan Yilmaz, Jean Baptiste Martin, Roman Sztajzel, Karl-Olof Lovblad Geneva Stroke Center
1 2

Figure 1. Carotid T thrombus

Figure 2. Pass 1 TICI1

Case Description
Male, 48 years old patient Patent foramen ovale Left hemiparesis, NIHSS 12 Presented 2h post-onset Failed EV Thrombolysis (0.6mg/kg in 30 minutes) Solitaire FR rst line device 2 passes with combined IA rtPA First pass 5mg Second pass 10mg Total 15mg delivered Final post-procedure TICI 3

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

Administration of medical therapy

High Rates of Recanalization*

Potential for improved patient outcomes Efficacious clot removal in vessels sized 2 to 5.5 mm

Figure 3. Pass 1 TICI1

Figure 4. Pass 2 TICI 2A

Results
Clot retrieval
* Data on file.

3 month follow-up NIHSS 0 mRS 0

Figure 5. Final control TICI 3

Figure 6. Final control TICI 3