Indications, Safety, and Warnings

Solitaire™ X Revascularization device

Indications for use

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.

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.

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.

Cautions

Caution: Federal (USA) law restricts this device to sale distribution and use by or on order of a physician. Indications, contraindications, warnings and instructions for use can be viewed at medtronic.com/manuals.

Precautions

The Solitaire™ X Revascularization device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.

Operators should take all necessary precautions to limit X-ray radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors whenever possible.

Carefully inspect the sterile package and the Solitaire™ X Revascularization device prior to use to verify that neither has been damaged during shipment. Do not use kinked or damaged components.

The Solitaire™ X Revascularization device is not to be used after the expiration date imprinted on the product label.

Refer to the appropriate intravenous tissue plasminogen activator (IV t-PA) manufacturer labeling for indications, contraindications, warnings, precautions, and instructions for use.

Initiate mechanical thrombectomy treatment as soon as possible.

For indication 3, endovascular therapy with the device should be started within 16 hours of symptom onset.

For indication 3, users should validate their imaging analysis techniques to ensure robust and consistent results for assessing core infarct size.

Contraindications

Use of the Solitaire™ X Revascularization device is contraindicated under these circumstances.

Patients with known hypersensitivity to nickel-titanium.

Patients with stenosis and/or pre-existing stent proximal to the thrombus site that may preclude safe recovery of the Solitaire™ X Revascularization device.

Patients with angiographic evidence of carotid dissection.

Potential complications

Possible complications include, but are not limited to the following:

Adverse reaction to antiplatelet/anticoagulation agents or contrast media

Air embolism

Allergic reactions

Angina

Arrhythmia

Arteriovenous fistula

Aspiration

Brain edema

Cancer

Change in mental status

Coagulopathy

Death

Device(s) deformation, collapse, fracture or malfunction

Distal embolization including to a previously uninvolved territory

Embolism

Fever

Fistula

Foreign body in patient

Foreign body reaction

Hemolysis

Hemorrhage

Hemorrhagic stroke

Hypersensitivity

Hypertension

Hypotension

Infarction, cerebral

Infection

Inflammation

Ischemia

Myocardial Infarction

Necrosis

Nerve damage

Neurologic deterioration including stroke progression, stroke in new vascular territory, and death

Organ failure

Pain

Perforation or dissection of the vessel

Persistent neurological deficits

Radiation exposure, unintended

Rupture

Shock

Stenosis

The risk of complication of radiation exposure (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia) increases as the procedure time and the number of procedures increase

Therapeutic response decreased

Thromboembolism

Thrombosis (acute and subacute)

Toxicity

User experiences major dissatisfaction with device performance

Vascular occlusion

Vasoconstriction (Vasospasm)

Vision symptoms

Warnings — all indications

The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice.

Administer IV t-PA as soon as possible for all patients who are indicated to receive the drug. Do not cause delays in this therapy.

Per IV t-PA manufacturer labeling, IV t-PA should be administered within 3 hours of stroke symptom onset. (IV t-PA use beyond 3 hours is not approved in the United States.)

Do not torque the Solitaire™ X Revascularization device.

For vessel safety, do not perform more than three recovery attempts in the same vessel using Solitaire™ X Revascularization devices.

For device safety, do not use each Solitaire™ X Revascularization device for more than three flow restoration recoveries.

For each new Solitaire™ X Revascularization device, use a new microcatheter.

Solitaire™ X Revascularization device does not allow for electrolytic detachment.

To prevent device separation:

Do not oversize device.
Do not recover (i.e.; pull back) the device when encountering excessive resistance. Instead, resheath the device with the microcatheter and then, remove the entire system under aspiration. If resistance is encountered during resheathing, discontinue and remove the entire system under aspiration.
Do not treat patients with known stenosis proximal to the thrombus site.

This device is supplied sterile for single use only. Do not reprocess or re-sterilize. Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance.

If excessive resistance is encountered during the delivery of the Solitaire™ X Revascularization device, discontinue the delivery and identify the cause of the resistance. Advancement of the Solitaire™ X revascularizaton device against resistance may result in device damage and/or patient injury.

If excessive resistance is encountered during recovery of the Solitaire™ X Revascularization device, discontinue the recovery and identify the cause of the resistance.

Advancing the microcatheter while the device is engaged in clot may lead to embolization of debris.

Do not advance the microcatheter against any resistance.

Do not reposition more than two times.

Warnings — indication 1 and 3 only

The safety and effectiveness has not been established for the Solitaire™ X Revascularization device to reduce disability in patients with the following:

Posterior circulation occlusions
More distal occlusions in the anterior circulation
Large core infarct (ASPECTS ≤7)

Disclaimer: This page may include information about products that may not be available in your region or country. Please consult the approved indications for use. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use.

The power package. Your talent. Our tools.

Solitaire™ X revascularization device

Together with your expertise and our devices,
we can power the future of stroke treatment.

See the device

Navigate tortuous anatomy with confidence.

First pass performance

The parametric design of the Solitaire™ X device offers reliable retrieval and optimal reperfusion rates.^1,2*

Optimal engagement

Self-expanding design provides multiple planes of contact for dynamic clot integration.^3,4*

Accurate visualization

Real-time visualization of the distinctive, evenly spaced platinum markers enables accurate alignment and feedback during the procedure with a 3-D perspective.^5*

Simple, effective, and clinically proven — the stent retriever that built the stroke community’s confidence in mechanical thrombectomy.^{1, 2, 6}

Optimize outcomes by minimizing the number of passes.^7-9

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.^10 †

See the data

Solitaire™ X device

See how the Solitiare™ X device can help you achieve the clinical outcomes you expect.

Product details

Clinical evidence

Read robust data about the most-published stent retriever.¹

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AIS portfolio

Discover 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.

^†

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

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

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.

TR-NV13807A, D00419703B.

⁴

TR-NV13807A, TR-NV15666AA, D00419703A, D00324045A.

⁵

TR-NV12692A.

⁶

Powers WJ, Derdeyn CP, Biller J, et al. 2015 American Heart Association/American Stroke Association focused update of the 2013 guidelines for the early management of patients with acute ischemic stroke regarding endovascular treatment: A guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2015;46(10):3020–3035.

⁷

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.

⁸

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

⁹

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.

¹⁰

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.

¹¹

TR-NV15436C, D00272862C, D00344794B, TR-NV15519A, TR-NV15666A.