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
Retrieve.
Revive.5
Solitaire FR™ Revascularization Device
Featuring Parametric™ DesignRestore
Flow
Unique stent-based
design. Fast flow
restoration.
design. Fast flow
restoration.
The Solitaire™ FR device's self-expanding stent-based
design creates a simple, single-operator procedure.1
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
Based on average of N=3 4x20
Solitaire™ FR Revascularization Devices
Case study images provided with permission by
Prof. Andersson, Karolinska Hospital, Stockholm, Sweden.
Prof. Andersson, Karolinska Hospital, Stockholm, Sweden.
Maximized radial force when deployed
within occlusion to facilitate fast flow
restoration.
within occlusion to facilitate fast flow
restoration.
Flow restoration to the MCA upon
deployment of the Solitaire™ FR device.
deployment of the Solitaire™ FR device.
Retrieve
Clot
Maximize clot
retrieval. An average
of 1.7 passes per
procedure.5
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
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 Devices.
Solitaire™ FR Revascularization Device
in a 3mm vessel.
in a 3mm vessel.
Parametric™ Design preserves cell-size
over varying vessel diameters.
over varying vessel diameters.
An optimal balance of navigability, wall-
apposition, and clot retention.
apposition, and clot retention.
SWIFT Study: Recanalization Rates5
Revive
Neurological
Tissue5
Next generation
technology.
Revolutionary
clinical results.
technology.
Revolutionary
clinical results.
Compared to the Merci Retriever® the Solitaire™
FR device provides a 2.5x improvement in
successful recanalization
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.
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®.
improvement in good neurological outcomes
at 90 days vs. the Merci Retriever®.
Solitaire™ FR device reduces mortality by
55% compared to the Merci Retriever®.
55% compared to the Merci Retriever®.
Revolutionizing Mechanical Thrombectomy with Parametric™ Design5
Solitaire™ FR
Device
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
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.
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
COVIDIEN, COVIDIEN with logo, and Covidien logo are US and internationally registered trademarks of Covidien AG. ® Trademark of its respective owner. Other brands are trademarks of a Covidien company. © 2012 Covidien. 76441-001 (A) FEB/12
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
COVIDIEN, COVIDIEN with logo, and Covidien logo are US and internationally registered trademarks of Covidien AG. ® Trademark of its respective owner. Other brands are trademarks of a Covidien company. © 2012 Covidien. 76441-001 (A) FEB/12