Healthcare Professionals

Solitaire Platinum Revascularization Device

Stent Retriever Thrombectomy for Acute Ischemic Stroke

Overview

The Solitaire™ Platinum revascularization device, featuring Parametric™ design, a unique overlapping stent retriever-based technology, 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 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™ Platinum 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™ Platinum 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 Platinum device is comprised of a nitinol scaffolding design attached to a pushwire. The Solitaire Platinum 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. 

Align it. Visualize it. Retrieve it.

We've retained the key features that make the Solitaire device effective – including our unique Parametric overlapping stent design – but Solitaire Platinum devices are enhanced with distinctive, evenly spaced platinum markers to provide improved visualization for accurate alignment and retrieval.2 

Together, this powerful combination of features gives you greater confidence during interventional stroke procedures.

Parametric Design

Unique3,4 overlapping 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 structure3
  • Limiting device elongation and foreshortening3
  • Providing multiple planes of clot integration contact3,4

OPTIMIZED FOR DYNAMIC CLOT INTEGRATION AND RETRIEVAL5

The 6x40 length device simplifies placement with proximal ophthalmic alignment providing complete visualization and coverage from M2 to ICA.6, 7

Solitaire Platinum Revascularization Device

View the features and simulated use of the Solitaire Platinum revascularization device.

CLINICAL EVIDENCE

Clinical studies prove the Solitaire device reduces stroke-related disability in patients suffering large vessel acute ischemic stroke (AIS) following IV t‑PA. Learn more.

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

Minimum Microcatheter ID

 

Push Wire Length

 

Stent Diameter

 

Usable Length

Proximal Marker to Distal Marker Length

 

Radiopaque Markers

Radiopaque Stent Marker Spacing

Length from Distal Tip to Fluorosafe Marker

(mm)

(mm)

(in)

(cm)

(mm)

(mm)

(mm)

Distal

Prox.

(mm)

(cm)

SFR3-4-20-05

2.0 – 4.0

0.5

.021

180

4.0

20.0

31.0

3

1

5

<130

SFR3-4-20-10

2.0 – 4.0

0.5

.021

180

4.0

20.0

31.0

3

1

10

<130

SFR3-4-40-10

2.0 – 4.0

0.5

.021

180

4.0

40.0

50.0

3

1

10

<130

SFR3-6-20-10

3.0 – 5.5

0.7

.027

180

6.0

20.0

31.0

4

1

10

<130

SFR3-6-24-06

3.0 – 5.5

0.7

.027

180

6.0

24.0

37.0

4

1

6

<130

SFR3-6-40-10

3.0 – 5.5

0.7

.027

180

6.0

40.0

47.0

4

1

10

<130


FOOTNOTE

*

Cello is a trademark of and is manufactured by Fuji Systems Corporation.


REFERENCES

1

510(k) K162539.

2

Medtronic Internal Report TR-NV12692

3

Medtronic Internal Report FD2815

4

Medtronic Internal Report FD2601

5

Medtronic Internal Report TR-NV13807 Rev A

6

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

7

Umansky, F. et al. Microsurgical anatomy of the proximal segments of the middle cerebral artery. J Neurosurg 61:458-467, 1984