Acute Ischemic Stroke Program - eV3

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Acute Ischemic Stroke Program - eV3

Clinical Education Comprehensive Stroke Portfolio

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

• Considerations for

Organizing a Stroke

Team and a Stroke Unit

• Develop Acute Ischemic

Stroke Protocols

• Improve Patient

Selection and

Treatment Parameters

• Discuss Acute Ischemic

Stroke Treatment

Evolution and Status

• Case Reviews and

Complications

• Hands-on Experience

Solitaire FR Revascularization Device

Catalog

Number

Recommended

Vessel Diameter

(mm)

Minimum

Micro Catheter

ID (in)

Push Wire

Length

(cm)

Diameter

(mm)

Usable

Length

(mm)

Total

Length

(mm)

Distal

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

SFR-6-30 3.0 – 5.5 0.027 180 6 30 42 4 1

Cello Balloon Guide Catheter

Catalog

Number

Product Name

Conformable

Sheath (F)

Tip Length

(mm)

Balloon

Length (mm)

ID (mm)

Effective

Length (cm)

Proximal

Markers

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

Catalog

Number (1/box)

105-5081-153 *C

OD (F) Distal ID (in)

Total Length

(cm)

Usable Length

(cm)

Max.

Guidewire (in)

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

Rebar 27 Reinforced Micro Catheter

Catalog

Number (1/box)

OD (F) Distal ID (in)

Total Length

(cm)

Usable Length

(cm)

*Dual Marker Band.

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

• 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

Diameter

Distal Markers

Total Length

Retrieval Zone

Solitaire FR

Device Stroke Kit

Configurations

Solitaire FR Device Stroke Kit 4x15

Solitaire FR device 4mm x 15mm

Cello 8F balloon guide catheter8 Rebar 18 micro catheter

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

Push Wire

Proximal Marker

Availability of product may vary by region. Please contact your Covidien sales representative regarding availability in your country.

COVIDIEN, COVIDIEN with logo, and Covidien logo are US and internationally registered trademarks of Covidien AG.

Trademark of a Covidien company.* Trademark of its respective owner. © 2012 Covidien. 115763-001 (A) APR/12 – Intl.

106-108 rue La Boétie

75008 Paris

France

+33 156 88 59 10 [t]

+33 156 88 59 11 [f]

www.covidien.com

• Clinical Studies

• Clinical Education

• Comprehensive Stroke Portfolio

Acute Ischemic Stroke Program

Solitaire FR

Revascularization Device


Solitaire FR Revascularization Device Clinical Studies

Restore Flow

Unique design.

Fast flow restoration.

The Solitaire FR device’s self-expanding

design creates a simple, single-operator

procedure. 1

Retrieve Clot

Maximize clot retrieval.

Minimize procedure time.

Solitaire FR device with Parametric

Design provides multiple planes of

clot contact to enhance capture. 2

Revive

Neurological Tissue 4

Next generation technology.

Revolutionary clinical results.

Solitaire FR revascularization device is the

most effective 5 mechanical thrombectomy

device combining the ability to immediately

restore blood flow, administer medical

therapy and retrieve clot in patients

experiencing acute ischemic stroke.

REVASCULARIzATION RATE

VESSEL WALL

Clot

Solitaire FR

Device deployed

VESSEL WALL

Depiction of a 4x20 Solitaire FR Device in a vessel.

96.0%

68.5%

Retrospective Study (TICI≥2a) SWIFT (TIMI≥2)

Radial Force (N/mm)

mm 2

RADIAL FORCE 3

0.08

0.06

0.04

0.02

0

CELL AREA 3

0.12

0.1

0.08

0.06

0.04

0.02

Deployment Retrieval

0.71 1 1.5 2 2.5

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.

0.095mm 2

81% of Area Maintained

0.1115mm 2

Based on an average of N=2 4x20 Solitaire 2.25mm

0.0

Cell Area in Constrained Tube.

FR Revascularization Devices.

2 3.0mm2 Parametric Design preserves cell-size over

varying vessel diameters which enhances clot

capture and retrieval.

3

3.5 4

FAST FLOW RESTORATION

Flow restoration to the MCA upon deployment of

the Solitaire FR device.

WALL APPOSITION 3

NEUROLOGICAL OUTCOMES MORTALITy RATE

54.6%

Retrospective Study

(mRS≤2)

36.0%

SWIFT

(mRS≤2)

58.2%

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.

Solitaire FR Revascularization

Device in a 3mm Vessel.

An optimal balance of navigability, wall-apposition,

and clot retention.

20.5%

17.2%

Retrospective Study SWIFT

Solitaire FR With Intention

For Thrombectomy (SWIFT) 7

Retrospective

Study 7

Principal Investigators (PI) J.L. Saver, U.S.A. N/A

Number of Patients

113

(58 Solitaire FR, 55 MERCI * )

Solitaire FR Thrombectomy for Acute

Revascularization (STAR) 7

V. Mendes Pereira, Switzerland

J. Gralla, Switzerland

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.

INITIAL ANGIOGRAM AFTER INITIAL DEPLOYMENT

For general inquiries or to learn more about

Physician Workshops and Centers of Excellence,

please email stroke@covidien.com

141

200

(enrolling)

Baseline NIHSS 17.3 18 (8-30)

Recanalization Rate

(TIMI≥2)

Revascularization Rate

(TICI≥2b)

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

SICH 6 1.7% 4% N/A

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 * .

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.

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.

Case study images provided with permission by Prof. Andersson, Karolinska Hospital, Helsinki, Sweden.

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