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 retrieval as well as:

• Maintaining consistent stent cell size and structure
• Differentiated radial outward force
• Providing multiple planes of clot integration contact

OPTIMIZED DELIVERY FOR IMPROVED EFFICIENCY

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

COMPLETE VISUALIZATION WITH COVERAGE FROM M2 TO ICA

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.

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

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.

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.

PRECAUTIONS

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

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

• Adverse reaction to antiplatelet/ anticoagulation agents or contrast media
• Air Embolism
• Allergic reactions
• Arteriovenous Fistula
• Brain Edema
• Change in mental status
• Device(s) deformation, collapse, fracture or malfunction
• Distal embolization including to a previously uninvolved territory
• Hematoma and hemorrhage at puncture site
• Infection
• Inflammation
• Intracranial Hemorrhage
• Ischemia
• Neurologic deterioration including stroke progression, stroke in new vascular territory, and death
• Perforation or dissection of the vessel
• Persistent neurological deficits
• Post procedure bleeding
• Pseudo aneurysm formation
• 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
• Thrombosis (acute and subacute)
• Vascular occlusion
• Vasoconstriction (Vasospasm)