Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 61779 - thrombectomy wire-net - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 58173 - embolectomy/thrombectomy suction catheter - 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. 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 58173 - embolectomy/thrombectomy suction catheter - the solitaire 2 is a self-expanding and fully retrievable nitinol mesh device.it is a stent-like device designed for the neurovasculature that can be fully deployed, fully resheathed and recovered. it provides technology to restore blood flow, retrieve clot and revive neurological tissue. the device has one proximal marker and either 3 or 4 distal markers, and the recommended vessel diameter ranges from 2.0 to 5.5mm. the solitaire 2 revascularisation device is designed to restore blood flow in patients experiencing ischaemic stroke due to large intracranial vessel occlusion. patients who are inelegible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment. 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 35449 - prosthesis, internal, embolization, intravascular - a self expanding detachable stent that can be completely and fully retrieved by a single operator that is intended to support the endovascular embolisation of intracranial aneurysms. the ev3 solitaire ab neurovascular remodeling device is designed for use as an adjunctive device in the treatment of intracranial aneurysms.

Singapore - English - HSA (Health Sciences Authority)

covidien private limited - neurology - “the ev3 solitaire™ ab neurovascular remodeling device is designed for use as an adjunctive device in the treatment of intracranial aneurysms. the solitaire™ detachment system is intended for use with the solitaire™ device. the solitaire™ detachment system is not intended to be used with coils.”

Singapore - English - HSA (Health Sciences Authority)

covidien private limited - neurology - the solitaire™ fr revascularization device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke (sfr models are indicated for use within 8 hours of symptom onset.). patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment.the ev3 solitaire™ fr revascularization device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.

Singapore - English - HSA (Health Sciences Authority)

covidien private limited - neurology - the solitaire™2 revascularization device is intended 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 intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd -

Singapore - English - HSA (Health Sciences Authority)

covidien private limited - neurology - the solitaire™ x revascularization device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment. the solitaire™ x revascularization device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke

Singapore - English - HSA (Health Sciences Authority)

covidien private limited - neurology - 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. the solitaire™ platinum revascularization device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. patients whoare ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment.