Solitaire™ FR Revascularization Device - eV3

Solitaire FR Revascularization Device
Unique stent-based design.
Maximize clot retrieval.
Fast flow restoration.
An average of 1.7 passes
per procedure. 5
Restore Flow Revive
Neurological
Tissue 5
Retrieve Clot
Radial Force (N/mm)
RADIAL FORCE 4
0.08
0.06
0.04
0.02
0
Maximized radial force when deployed within
occlusion to facilitate fast flow restoration.
REFERENCES
Deployment Retrieval
0.71 1 1.5 2 2.5 3 3.5 4
Constrained Diameter (mm)
Based on an average of N=3 4x20
Solitaire FR Revascularization Devices
The Solitaire FR device’s self-expanding stent-based
design creates a simple, single-operator procedure. 1 Solitaire FR device with Parametric Design
provides multiple planes of clot contact to
enhance capture. 2
FAST FLOW RESTORATION
INITIAL ANGIOGRAM AFTER INITIAL DEPLOYMENT
Case study images provided with permission by Prof. Andersson, Karolinska Hospital, Stockholm, Sweden.
Flow restoration to the MCA upon deployment of
the Solitaire FR device.
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.
mm 2
0.12
0.1
0.08
0.06
0.04
0.02
0.0
CELL AREA 4 WALL APPOSITION 4
.095mm 2
81% of area maintained
.1115mm 2
2.25mm 2 3.0mm 2
Cell Area in constrained tube.
Based on an average of N=2 4x20 Solitaire FR Revascularization Devices.
Parametric Design preserves cell-size over varying
vessel diameters.
VESSEL WALL
Clot
Solitaire FR
Device deployed
VESSEL WALL
Depiction of a 4x20 Solitaire FR Device in a vessel.
Solitaire FR Revascularization Device in a 3mm vessel.
An optimal balance of navigability, wall-apposition,
and clot retention.
Next generation technology.
Revolutionary clinical results.
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.
SWIFT Study: Recanalization Rates 5
Solitaire FR
Device 37/54
SWIFT STUDY: Neurological Outcomes 5 SWIFT STUDY: Mortality Rates 5
58.2%
Solitaire FR Device
32/55
33.3%
Merci Retriever®
16/48
Solitaire FR device demonstrates a 1.7x
improvement in good neurological outcomes at 90
days vs. the Merci Retriever ®.
60.7%
24.1%
Merci Retriever®
16/53
CORE LAB REVIEWED
Superiority p-value 0.0001
Solitaire FR
Device 45/54
Compared to the Merci Retriever ® the Solitaire
FR device provides a 2.5x improvement in
successful recanalization.
17.2%
Solitaire FR Device
10/58
83.3%
Merci Retriever®
21/55
48.1%
Merci Retriever®
26/54
SITE REPORTED
Superiority p-value 0.0002
38.2%
Solitaire FR device reduces mortality by 55%
compared to the Merci Retriever ®.