Stent, vascular, intracranial

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Beschikbaar vanaf:

AA-Med Pty Ltd

klasse:

Class I

Geproduceerd door:

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

Therapeutisch gebied:

46352 - Stent, vascular, intracranial

therapeutische indicaties:

Used in combination with the NeuroSpeed? PTA Balloon Catheter, the CREDO? heal Stent is indicated to increase the vessel diameter of intracranial arteries (for example the ICA, MCA, VA/V4, BA) that are suitable for and accessible to the system (stent with PTA balloon catheter) in patients: ? 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), ? over 18 years old, ? whose last stroke occurred at least 7 days before and in whom the impairment after stroke has a rating of 3 or less on the modified Rankin scale (mRS) at the time of treatment. or ? with evidence of intracranial large vessel 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 thrombectomy (CT ASPECTS 6-10, DWI lesion < 70 ml).

Autorisatie-status:

A

Autorisatie datum:

2023-04-12