Healthcare Professionals
Solitaire Revascularization Device
Stent Retriever Thrombectomy for Acute Ischemic Stroke
Overview
The Solitaire™ revascularization device, featuring Parametric™ technology, a unique overlapping stent retriever-based design, restores blood flow and retrieves clots from occluded blood vessels in the brain for patients experiencing acute ischemic stroke (AIS) due to a large vessel occlusion (LVO).
In fact, the Solitaire device is now indicated to reduce stroke-related disability by showing nearly 70% relative improvement in functional outcomes at 90 days in patients suffering LVO.1
INDICATIONS
The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
The Solitaire™ Revascularization Device is indicated 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 IV t-PA or who fail IV t-PA therapy are candidates for treatment.
Product Details
The Solitaire device is comprised of a nitinol scaffolding design attached to a pushwire. The Solitaire device is designed to be delivered through a micro catheter, deployed across a clot, and removed along with the clot to enable revascularization of the occluded intracranial vessel.
Parametric Design
Unique4,5 overlapping stent retriever-based design allows the device to expand in larger vessels and compress in smaller vessels during deployment and retrieval all while:
- Maintaining consistent cell size and structure4
- Limiting device elongation and foreshortening4
- Providing multiple planes of clot integration contact4,5
Align, Visualize, Retrieve
Retaining the same effective Parametric design3-5 as the original Solitaire FR and subsequent Solitaire 2 devices, the Solitaire Platinum devices are enhanced with distinctive evenly spaced platinum markers to provide improved visualization6 for accurate alignment and retrieval.
4x40
The 4x40 length device simplifies placement with proximal ophthalmic alignment providing complete coverage of the stroke zone from ICA to M2.2
Solitaire Platinum Revascularization Device - (02:47)
View the features and simulated use of the Solitaire Platinum revascularization device.
Mer information (se mer)
Se mindre
CLINICAL EVIDENCE
Review summaries of published studies supporting the use of Solitaire devices for treatment of acute ischemic stroke.
Stroke Access Devices
See the Neurovascular Product Catalog for information about these related products.
- Arc™ Intracranial Support Catheter
- Cello™ Balloon Guide Catheter
- Rebar™ Micro Catheter
MANUALS AND TECHNICAL GUIDES
Solitaire Revascularization Device Instructions for Use
This technical manual includes indications, warnings, precautions, product specifications, instructions, and clinical study summary. Find in the product labeling supplied with each device or call Medtronic at 800-961-9055.
MODEL SPECIFICATIONS
| Order Number | Recommended Vessel Diameter (mm) | Device Diameter (mm) | Minimum Micro Catheter ID (in) | Push Wire Length (cm) | Distal Markers | Proximal Markers | Usable Length (mm) | Proximal Marker to Distal Marker Length (mm) |
|---|---|---|---|---|---|---|---|---|
|
SFR3-4-20-10 |
2.0 – 4.0 |
4 |
0.021 |
180 |
3 |
1 |
20 |
31 |
| SFR3-4-40-10 |
2.0 – 4.0 |
4 |
0.021 |
180 |
3 |
1 |
40 |
50 |
| SFR3-6-20-10 |
3.0 – 5.5 |
6 |
0.027 |
180 |
4 |
1 |
20 |
31 |
| SFR2-4-15 | 2.0 – 4.0 |
4 |
0.021 |
180 |
3 |
1 |
15 |
26 |
|
SFR2-4-20 |
2.0 – 4.0 |
4 |
0.021 |
180 |
3 |
1 |
20 |
31 |
|
SFR2-4-40 |
2.0 – 4.0 |
4 |
0.021 |
180 |
3 |
1 |
40 |
50 |
|
SFR2-6-20 |
3.0 – 5.5 |
6 |
0.027 |
180 |
4 |
1 |
20 |
31 |
| SFR2-6-30 | 3.0 – 5.5 |
6 |
0.027 |
180 |
4 |
1 |
30 |
42 |
FOOTNOTE
*
Cello is a trademark of and is manufactured by Fuji Systems Corporation.
REFERENCES
1
510(k) K162539.
2
Pai S.B., et, al. Microsurgical Anatomy of the Middle Cerebral Artery. Neurology India. June 2005. Vol 53. Issue 2. Keshelava G. et, al. Surgical anatomy of petrous part of the internal carotid artery. Neuroanatomy (2009) 8: 46–48
3
Saver JL, Goyal M, Bonafe A, et al. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N. Engl. J. Med. Jun 11 2015;372(24):2285-2295.
4
Medtronic Internal Report FD2815
5
Medtronic Internal Report FD2601
6
Medtronic Internal Report TR-NV12692