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1. The Solitaire™ 2 and Solitaire ™ Platinum Revascularization Devices is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute 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™ 2 and Solitaire TM Platinum Revascularization Devices 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™ 2 and Solitaire™ Platinum Revascularization Devices is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion in the neurovasculature such as the internal carotid artery (ICA), M1 and M2 segments of the middle cerebral artery, basilar and the vertebral arteries. The distal nitinol portion of the subject device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends and, for some SKUs, at several locations along the body of the stent. The devices are supplied sterile and are intended for single-use only.