Device Dossier

Solitaire Platinum™ Revascularization Device - Embolectomy/thrombectomy suction catheter

Device Dossier for Solitaire Platinum™ Revascularization Device - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter,…

Intended purpose

The Solitaire Platinum 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; and the 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.

Functional description

The Solitaire Platinum™ device is a nitinol, self-expanding retrieval device which can be fully deployed, fully resheathed and recovered. Radiopaque markers are added around the circumference of the retriever at intervals along its working length.

TGA Public Summary