Stent, vascular, intracranial

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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下载 公众评估报告 (PAR)
20-07-2023

可用日期:

AA-Med Pty Ltd

类:

Class I

厂商:

Acandis GmbH Theodor-Fahrner-Strasse 6, Pforzheim, 75177 Germany

治疗领域:

46352 - Stent, vascular, intracranial

疗效迹象:

The Credo? Stent is indicated to increase the vessel diameter of intracranial arteries that are suitable for and accessible to the system (stent with PTA balloon catheter) inpatients: ? with arteriosclerotic (probable according to clinical, anamnestic or laboratory chemical testing) vessel constrictions (high-grade intracranial stenoses > 70%) with significant circulatory disturbance (haemodynamic infarct pattern and indication of restricted collaterals) in spite of intensive medication therapy, ? with recurrent symptoms in spite of antiaggregation therapy(therapy-refractory) after at least two events (stroke), ? aged 18 to 80, ? whose last stroke occurred at least 7 days before and in whom the impairment after stroke has a rating of 3 or lesson the modified Rankin scale (mRS) at the time of treatment. OR ? with evidence of intracranial large vassal occlusion (LVO) ? over 18 years old, -with acute persistent vascular occlusion due to high-grade intracranial stenosis for which alternative therapy concepts are not considered or fail ? with suspected underlying stenosis of the occluded artery, which is suitable for PTA and stenting according to the treating physician's assessment, ? with small to moderate infarct core prior to initiation of thromectomy (CT ASPECTS 6-10. DWI lesion < 70ml)

授权状态:

A

授权日期:

2022-10-26

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