Solitaire X revascularization device helps stroke patients.

SOLITAIRE X


Clot Retrieval Thrombectomy for Acute Ischemic Stroke


The Solitaire™ X 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).
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Alert Indications, Safety, and Warnings

OVERVIEW

A DIFFERENCE YOU CAN FEEL1
WITH PRECISION YOU CAN SEE2

The Solitaire™ X portfolio is designed to give you greater confidence during interventional stroke procedures with:

  • Unique Parametric design for dynamic clot integration3,4
  • Differentiated radial outward force4,5
  • Complete visualization and coverage from M2 to ICA4,6
  • Optimized delivery system produces lower delivery force1,7 for procedural efficiency and smooth navigation
  • Robust clinical evidence21

 

 

PRODUCT DETAILS

UNIQUE PARAMETRIC DESIGN
for Dynamic Clot Integration

The overlapping stent design allows the device to expand in larger vessels and compress in smaller vessels during deployment and retrieval3 as well as:

  • Maintaining consistent stent cell size and structure8
  • Differentiated radial outward force4,5
  • Providing multiple planes of clot integration contact3
Solitaire Revascularization Device

DYNAMIC CLOT INTEGRATION3,4

Solitaire X dynamic clot integration specifications.

DIFFERENTIATED
RADIAL OUTWARD FORCE4,5    

Differentiated Radial Outward Force

OPTIMIZED DELIVERY
for Improved Efficiency1,7

Our Solitaire X Revascularization Device — designed with an optimized delivery system — produces lower delivery force7 for improved procedural efficiency and smooth navigation through even the most complicated anatomy.

Solitaire X requires lower delivery force
Solitaire X product image showing easy deliverability

COMPLETE VISUALIZATION
with Coverage from M2 to ICA4,6

The distinctive, evenly-spaced platinum markers let you visualize the optimal working length and stent behavior for real-time procedural feedback, ensuring accurate alignment, optimal revascularization, and clot capture success.2

The 6x40 length device simplifies placement with proximal ophthalmic alignment, providing complete visualization and coverage from M2 to ICA.4,6    

Solitaire X clot crossing profile

ROBUST DATA
for Safety and Efficacy

Our Solitaire portfolio is backed by published data with 11+ trials and case studies worldwide, proving it reduces stroke-related disability in patients suffering a large vessel acute ischemic stroke following  IV t-PA.9-19

SEE CLINICAL EVIDENCE
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MORE OPTIONS
ACUTE ISCHEMIC STROKE Portfolio

Our AIS portfolio offers comprehensive, compatible solutions that give your patients a better chance to walk away from AIS. 

See the Neurovascular Product Catalog for more.

portfolio

ECONOMIC VALUE   

Data Supported

See how stroke treatment with the Solitaire device provides economic value.

MODEL SPECIFICATIONS

MANUALS AND TECHNICAL GUIDES

To view this technical manual please visit Medtronic.com/manuals or call
800-961-9055.

Solitaire X brochure

Solitaire X specifications sheet

AIS product brochure

Neurovascular product catalog

Solitaire coding and reimbursement guide

Model Specifications
table

MORE ABOUT SOLITAIRE AND THE AIS PORTFOLIO    

The Solitaire X portfolio is designed to give you greater confidence during interventional stroke procedures.    

Learn about the decade of Solitaire innovation.
More information (see more) Less information (see less)

Brianne was 24 when she had her first stroke. Watch her story.

STROKE CARE RESOURCES


Your proven partner for world-class stroke care solutions.

 

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CONTACT & CONNECT

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U.S. Clinician Services
877-526-7890

rs.cstechsupport@medtronic.com

INDICATIONS

1. The Solitaire X 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.

2. The Solitaire X 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.

3. The Solitaire X 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 of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (<70 cc by CTA or MRA, <25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

*

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

1

TR-NV16168 Rev A

2

TR-NV12692 Rev A

3

TR-NV13807 Rev A

4

TR-NV15666A Rev A

5

TR-NV12180 Rev A

6

Umansky, F. et al. Microsurgical anatomy of the proximal segments of the middle cerebral artery

7

Compared to Solitaire™ Platinum

8

TR-NV12554 Rev A

9

Goyal M, Demchuk AM, Menon BK, et al. Randomized assessment of rapid endovascular treatment of ischemic stroke. N. Engl. J. Med. Mar 12 2015;372(11):1019-1030.

10

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.

11

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.

12

TN Nguyen & Al. Balloon Guide Catheter Improves Revascularization and Clinical Outcomes With the Solitaire Device. Stroke. 2014;45:141-145.

13

Serge Bracard, Xavier Ducrocq, et al. Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke (THRACE): a randomized controlled trial. Lancet Neurol. 2016; 15: 1138–47.

14

Jovin TG, Chamorro A, Cobo E, et al. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N. Engl. J. Med. Jun 11 2015;372(24):2296-2306.

15

Berkhemer OA, Fransen PS, Beumer D, et al. A randomized trial of intraarterial treatment for acute ischemic stroke. N. Engl. J. Med. Jan 1 2015;372(1):11-20.

16

Pereira VM, Gralla J, Davalos A, et al. Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke. Stroke. Oct 2013;44(10):2802-2807.

17

Campbell BC, Mitchell PJ, Kleinig TJ, et al. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N. Engl. J. Med. Mar 12 2015;372(11):1009-1018.

18

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 randomized trials. Lancet. Apr 23 2016;387(10029):1723-1731. 

19

Campbell BC, Hill MD, Rubiera M, et al. Safety and Efficacy of Solitaire Stent Thrombectomy: Individual Patient Data Meta-Analysis of Randomized Trials. Stroke; a journal of cerebral circulation. 2016;47(3):798-806.

20

71042-001 Rev B

21

STRATIS, SWIFT PRIME, ESCAPE, Nasa Registry, THRACE, MR CLEAN, STAR, EXTEND IA, HERMES, SEER, REVASCAT, DEFUSE 3, Note: The Solitaire™ X Revascularization Device was not evaluated in these studies.

22

Phenom 21 Catheter