Solitaire X Revascularization Device - Thrombectomy wire-net

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Medtronic Australasia Pty Ltd

Class:

Class III

Manufactured by:

Micro Therapeutics Inc DBA ev3 Neurovascular 9775 Toledo Way, Irvine, CA, 92618 United States Of America

Therapeutic area:

61779 - Thrombectomy wire-net

Therapeutic indications:

The Solitaire? X Revascularization Device is designed to restore blood flow by removing thrombus in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The device is designed for use in the neurovasculature such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. 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.

Authorization status:

A

Authorization date:

2020-05-15