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Flow Restoration

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

Restore.
Retrieve.
Revive.5

Solitaire FR™ Revascularization Device

Featuring Parametric™ Design

Restore
Flow

Unique stent-based
design. Fast flow
restoration.
The Solitaire™ FR device's self-expanding stent-based
design creates a simple, single-operator procedure.1
RADIAL FORCE
FAST FLOW RESTORATION
Constrained Diameter (mm)
Based on average of N=3 4x20
Solitaire™ FR Revascularization Devices
Case study images provided with permission by
Prof. Andersson, Karolinska Hospital, Stockholm, Sweden.
Maximized radial force when deployed
within occlusion to facilitate fast flow
restoration.
Flow restoration to the MCA upon
deployment of the Solitaire™ FR device.

Retrieve
Clot

Maximize clot
retrieval. An average
of 1.7 passes per
procedure.5
 
Solitaire™ FR device with Parametric™ Design
provides multiple planes of clot contact to
enhance capture.2
CELL AREA 4
WALL APPOSITION 4
Based on an average of N=2 4x20
Solitaire™ FR Revascularization Devices.
Solitaire™ FR Revascularization Device
in a 3mm vessel.
Parametric™ Design preserves cell-size
over varying vessel diameters.
An optimal balance of navigability, wall-
apposition, and clot retention.
SWIFT Study: Recanalization Rates5

Revive
Neurological
Tissue5

Compared to the Merci Retriever® the Solitaire™
FR device provides a 2.5x improvement in
successful recanalization
SWIFT STUDY: Neurological Outcomes 5
SWIFT STUDY: Mortality Rates 5
 
 
Good neurological outcome defined as mRS ≤ 2, or
equal to the prestrike mRS if the prestroke mRS was
higher than 2, or NIHSS score improvement of 10
points or more.
Solitaire™ FR device demonstrates a 1.7x
improvement in good neurological outcomes
at 90 days vs. the Merci Retriever®.
Solitaire™ FR device reduces mortality by
55% compared to the Merci Retriever®.
Revolutionizing Mechanical Thrombectomy with Parametric™ Design5
Solitaire™ FR
Device
The Solitaire™ FR revascularization device
with Parametric™ Design, an overlapping
stent-based design, provides revolutionary
technology to restore flow, retrieve clot, and
revive neurological tissue.5
A size matrix of 4 mm and 6 mm diameters optimizes
performance in the MCA, Carotid, and Basilar arteries.
Solitaire™ FR Revascularization Device Ordering Information
Reference Number Recommended
Vessel Diameter
(mm)
(A) Total Length (mm) (B) Retrieval Zone (mm) (C) Device Diameter
(mm)
(D) Push
Wire Length
(cm)
(E) Distal Markers (F) Proximal Markers Minimum
Micro
Catheter
ID (in)
SFR-4-15 2.0 – 4.0 26 15 4 180 3 1 0.021
SFR-4-20 2.0 – 4.0 31 20 4 180 3 1 0.021
SFR-6-20 3.0 – 5.5 31 20 6 180 4 1 0.027
SFR-6-30 3.0 – 5.5 42 30 6 180 4 1 0.027
Rebar™ Reinforced Micro Catheters Ordering Information
Reference Number Catheter Class Usable Length (mm) Maximum Guidewire ID (in) Minimum Guidewire ID (in) (Proximal OD Distal OD
105-5081-153a 18 153 0.021 0.018 2.7 F 2.4 F
105-5083-153 18 153 0.021 0.018 2.7 F 2.4 F
105-5082-130 27 130 0.027 0.018 2.8 F 2.8 F
105-5082-145 27 145 0.027 0.018 2.8 F 2.8 F
For general inquiries or to learn more about our Physician Workshop and Center of Excellence, please email stroke@covidien.com
REFERENCES
1. Design Specification: PS08-001F.
2. Covidien Testing Data: FD2601A.
3. TR08-136: In Vivo Evaluations of Solitaire™ FR Devices for Flow Restoration in a Chronic Swine Model
4. FD2815: Competitive Device Test Plan-Flow Restoration Device.
5. Solitaire™ FR with the Intention for Thrombectomy (SWIFT) Study SWIFT IDE # G090082 FD2923. Solitaire

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