SolitaireTM X Revascularization device

The Solitaire™ X device is a revascularization device designed for effective clot retrieval during thrombectomy procedures for acute ischemic stroke patients.

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Overview

Overview

The Solitaire™ device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance.1,2
The Solitaire™ X device has a unique parametric design that has been fundamental to the generations of the Solitaire™ portfolio.

  • This overlap design allows the stent to expand and compress in the vessel during deployment and retrieval. 
  • The distinctive, evenly spaced platinum markers enable accurate alignment and feedback during the procedure with a three-dimensional perspective.3* 

Product details

Conform to anatomy with wall apposition and dynamic clot integration4,5*

  • Maintains consistent cell size and structure over varying vessel diameters6*
  • Provides multiple planes of contact to integrate with the clot, even double layering in smaller vessels7*

Percent overlap by vessel diameter5*

Solitaire™ X device vessel diameterst

Visualize accuracy with real-time imagery

  • Meaningful visibility with real-time visualization of the radiopaque markers
  • Evaluate clot composition through body marker integration into the clot
    • Visualize the expansion and compression of the stent to help identify clot characteristics8    

X-ray of a soft clot and the Solitaire™ X revascularization device

X-ray of a hard clot and the Solitaire™ X revascularization device

Images courtesy of Dr. Alejandro Tomasello Weitz

Encapsulate the clot without damaging the wall9†

Differentiated radial outward force promotes clot and vessel wall contact during retrieval with the optimal amount of radial force.10*

Solitaire™ X differentiated outward force - 3x20

Solitaire™ X differentiated outward force - 4x40

Solitaire™ X differentiated outward force - 6x40

Clinical evidence

Optimize outcomes by minimizing the number of passes11-13

A large real-world patient cohort demonstrated a first pass effect (FPE) rate of 40.5% and a modified FPE (mFPE) rate of 58.9% across patients treated with the Solitaire™ device.14‡

Achieve the clinical outcomes you expect

A large real-world patient cohort demonstrated the following results with the Solitaire™ device.15

87.9%

Successful reperfusion

(mTICI 2b-3, core-lab adjudicated)

56.5%

modified Rankin Scale (mRS) 0–2 at 90 days

1.4%

Symptomatic intercranial hemorrhage (sICH)

Tested and trusted for total confidence

Ordering information

Solitaire™ X device with components labeled


Solitaire X revascularization device portfolio information16

Model Recommended Vessel DiameterA (mm) Microcatheter ID Range Push Wire Length Stent Diameter Usable LengthB Stent Length Length from Distal Tip to Flourosafe Marker Radiopaque Markers Radiopaque Stent Markers Spacing
  (min) (max) (min–max) (cm) (mm) (mm) (mm) (cm) Distal Prox. (mm)
SFR4-3-20-10 1.5 3.0 0.017″–0.027″
0.43 mm–0.69 mm
200 3.0 20.0 30.6 <150 3 1 10
SFR4-3-40-10 1.5 3.0 0.017″–0.027″
0.43 mm–0.69 mm
200 3.0 40.0 51.6 <150 3 1 10
SFR4-4-20-05 1.5 4.0 0.021″–0.027″
0.53 mm–0.69 mm
200 4.0 20.0 31.0 <130 3 1 5
SFR4-4-20-10 1.5 4.0 0.021″–0.027″
0.53 mm–0.69 mm
200 4.0 20.0 31.0 <130 3 1 10
SFR4-4-40-10 1.5 4.0 0.021″–0.027″
0.53 mm–0.69 mm
200 4.0 40.0 50.0 <130 3 1 10
SFR4-6-20-10 2.0 5.5 0.021″–0.027″
0.53 mm–0.69 mm
200 6.0 20.0 31.0 <130 4 1 10
SFR4-6-24-06 2.0 5.5 0.021″–0.027″
0.53 mm–0.69 mm
200 6.0 24.0 37.0 <130 4 1 6
SFR4-6-40-10 2.0 5.5 0.021″–0.027″
0.53 mm–0.69 mm
200 6.0 40.0 47.0 <130 4 1 10

A. Based on smallest vessel diameter at thrombus site.
B. Usable length that is at least as long as the length of the thrombus.

Up to 3 flow restoration recoveries16
 

For a compatible microcatheter to help you smoothly navigate through even the most complicated anatomy, choose from the Phenom™ 21 or 27 catheter to deliver the Solitaire™ X device.

AIS therapies

Medtronic creates meaningful technologies to empower AIS physicians.

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Clinical evidence

Read robust data about the safety and efficacy of the Solitaire™ revascularization device.

View the data

AIS portfolio

See our stroke products, from stent retrievers to aspiration systems.
 

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*

Based on bench testing results. Bench testing may not be representative of actual clinical performance.

Based on bench and animal testing results. Bench and animal testing may not be representative of actual clinical performance.

FPE defined as mTICI2c/3; modified FPE defined as mTICI 2b-3.

1

Medtronic Data on File. Solitaire Literature Review Aug2022. Includes Solitaire FR, Solitaire 2, Solitaire Platinum, Solitaire X.

2

Goyal M, Menon BK, van Zwam WH, et al. Endovascular thrombectomy after large-vessel ischaemic stroke: A meta-analysis of individual patient data from five randomised trials. Lancet. 2016;387(10029):1723-1731.

3

TR-NV12692A

4

TR07-128B

5

TR-NV13807A, TR-NV15666A, D00419703A, D00324045A

6

TR-NV12554A

7

TR-NV13807A, D00419703A

8

Tomasello A. The best of both worlds: Combination therapy for ischemic stroke. Oral presentation at: International Stroke Conference; February 9, 2022; New Orleans, LA.

9

D00188173B

10

D00419703B

11

García-Tornel Á, Requena M, Rubiera M, et al. When to Stop [published correction appears in Stroke. 2020 Jun;51(6):e118]. Stroke. 2019;50(7):1781-1788.

12

Zaidat OO, Castonguay AC, Linfante I, et al. First pass effect: A new measure for stroke thrombectomy devices. Stroke. 2018;49(3):660-666.

13

Flottmann F, Leischner H, Broocks G, et al. Recanalization rate per retrieval attempt in mechanical thrombectomy for acute ischemic stroke. Stroke. 2018;49(10):2523-2525.

14

Jadhav AP, Desai SM, Zaidat OO, et al. First pass effect with neurothrombectomy for acute ischemic stroke: Analysis of the systematic evaluation of patients treated with stroke devices for acute ischemic stroke registry. Stroke. 2022;53(2):e30-e32. Includes Solitaire FR, Solitaire 2.

15

Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Systematic evaluation of patients treated with neurothrombectomy devices for acute ischemic stroke: primary results of the STRATIS registry. Stroke. 2017;48(10):2760-2768.

16

M003592CDOC2

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