SOLITAIRETM X Clot Retrieval Thrombectomy for Acute Ischemic Stroke

Solitaire™ X is  a new generation revascularization device with a unique parametric design, featuring an overlapping technology, providing physicians with improved delivery performance, effective clot retention and faster flow restoration timelines, designed to be deployed  with a lower microcatheter profile, to provide expanded ease of delivery.

SEE ALL ACUTE ISCHEMIC STROKE DEVICES

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
COIL
CLOT

DIFFERENTIATED RADIAL
OUTWARD FORCE4,5

RADIAL

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.

LOWER DELIVERY FORCE1,7

47
PUSHWIRE

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

17

ROBUST DATA
FOR SAFETY AND EFFICACY

Our SolitaireTM 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

DATA

MORE OPTIONS 
BETTER CONTROL

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

A comprehensive portfolio for all AIS techniques.

options

ECOMONIC VALUE

DATA SUPPORTED

See how stroke treatment with the SolitaireTM device provides economic value in UK.

SPECIFICATIONS

INDICATIONS

The Solitaire™ X revascularization device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

IFU

 

View full instructions for use

Solitaire X IFU (pdf)

Characteristics

  • Min. Microcatheter ID: 0.021”
  • Pushwire Length: 200cm
  • Length from Distal Tip to Flurorosafe marker: <130cm
  • Proximal Radiopaque Marker: 1

Available CFNs

CFN Rec. Vessel Diameter (mm) Stent Diameter (mm) Usable/Stent Lengths (mm) Distal Radiopaque Markers Radiopaque Markers Spacing (mm)

SFR4-4-20-05

2.0-4.0

4.0

20.0/31.0

3

5

SFR4-4-40-10

2.0-4.0

4.0

40.0/50.0

3

10

SFR4-6-24-06

2.0-5.0

6.0

24.0/37.0

4

6

SFR4-6-40-10

2.0-5.5

6.0

40.0/47.0

4

10

ANY QUESTIONS?

Do you need support for procedures? Or information on our products and solutions?

Our team is happy to help answer any questions you may have.

CONTACT US

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1

TR-NV16168 Rev A

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TR-NV12180 Rev A

6

Umansky F, Juarez SM, Dujovny M, et al. Microsurgical anatomy of the proximal segments of the middle cerebral artery. J Neurosurg. 1984;61(3):458-467. doi:10.3171/jns.1984.61.3.0458

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.

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Phenom 21 Catheter