Solitaire™ FR Revascularization Device

Solitaire™ FR Revascularization Device

Revolutionizing Mechanical Thrombectomy with Parametric™ Design
A size matrix of 4 mm and 6 mm diameters optimizes performance in the MCA, Carotid,
and Basilar arteries.
Solitaire™ FR
Device
Solitaire™ FR Revascularization Device Ordering Information
The Solitaire™ FR revascularization device
featuring Parametric™ design, an overlapping
stent-based technology, provides revolutionary
technology to restore flow, retrieve clot, and
revive neurological tissue.5
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
Solitaire™ FR
Revascularization Device
FEATURING PARAMETRIC™ DESIGN
Rebar® Micro Catheter Ordering Information
Reference
Number
Catheter
Class
Usable Length
(mm)
Maximum
Guidewire ID (in)
Minimum
Guidewire ID (in)
Proximal
OD
Distal
OD
105-5081-153 a
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
a Dual
FASTER 5
Flow
Restoration
Marker Band.
DEVICE DETAILS
(A) Total Length
(B) Retrieval Zone
(C) Diameter
(D) Push Wire
IMPROVED
Clot
Retention
Introducer Sheath
5
PARAMETRIC™
DESIGN
BALANCED
Delivery
Performance
4
(E) Distal Markers
(F) Proximal Marker
For general inquiries or to learn more about our Physician Workshop and Center of Excellence, please email [email protected]
The Solitaire™ FR revascularization device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke
within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
76357-001 (B) APR/12
Indications, contraindications, warnings and instructions for use can be found on the product labeling supplied with each device. CAUTION: Federal (USA) law restricts this device
to sale by or on the order of a physician.
MAINTAIN 3
Intimal
Integrity
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5
Restore. Retrieve. Revive.
Solitaire™ FR Revascularization Device
Restore Flow
Retrieve Clot
Unique stent-based design.
Fast flow restoration.
Maximize clot retrieval.
An average of 1.7 passes
per procedure. 5
VESSEL WALL
Clot
Revive
Neurological
Tissue
5
Solitaire™ FR
Device deployed
SWIFT Study: Recanalization Rates 5
83.3%
60.7%
48.1%
24.1%
Next generation technology.
Revolutionary clinical results.
Solitaire™ FR
Device 37/54
V E SS E L WA LL
CORE LAB REVIEWED
Superiority p-value 0.0001
Depiction of a 4x20 Solitaire™ FR Device in a vessel.
The Solitaire™ FR device’s self-expanding stent-based
design creates a simple, single-operator procedure.1
Deployment
0.08
CELL AREA 4
Retrieval
INITIAL ANGIOGRAM
AFTER INITIAL DEPLOYMENT
0.12
WALL APPOSITION 4
81% of area maintained
0.1
0.08
SITE REPORTED
Superiority p-value 0.0002
SWIFT STUDY: Mortality Rates 5
.1115mm
38.2%
0.06
0.04
Merci Retriever®
26/54
58.2%
2
.095mm2
SWIFT STUDY: Neurological Outcomes 5
mm2
Radial Force (N/mm)
0.06
Solitaire™ FR
Device 45/54
Compared to the Merci Retriever® the Solitaire™
FR device provides a 2.5x improvement in
successful recanalization.
Solitaire™ FR device with Parametric™ Design
provides multiple planes of clot contact to
enhance capture.2
FAST FLOW RESTORATION
RADIAL FORCE 4
Merci Retriever®
16/53
33.3%
0.04
0.02
0.02
0
0.71
1
1.5
2
2.5
3
3.5
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.
4
17.2%
0.0
Case study images provided with permission by Prof. Andersson, Karolinska Hospital, Stockholm, Sweden.
2.25mm
2
3.0mm
2
Solitaire™ FR Device
32/55
Cell Area in constrained tube.
Flow restoration to the MCA upon deployment of
the Solitaire™ FR device.
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. Please see page 5 of this brochure for supporting study data.
Merci Retriever®
16/48
Solitaire™ FR Device
10/58
Merci Retriever®
21/55
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.
Good neurological outcome defined as mRS ≤ 2, or equal to the prestroke 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 ®.