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DMI/FDA/1.1.2/PED

Pipeline Flex Embolization Device, Medtronic – Sim&Size v1.1.2 Indication for use (P100018/S015) The Pipeline™ Flex embolization device is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. The Pipeline™ Flex …

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DMI/CE/1.2.7/Target

Target Target Standard / Target Soft / Target 3D / Target XL Standard / Target XL 360 Soft / Target XL Helical / Target 360 Ultra / Target Helical Ultra / Target 360 Nano  / Target Helical Nano /Target XXL 360, Stryker – Sim&Size v1.2.7 Indications for Use Target Detachable Coils are intended to endovascularly obstruct …

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DMI/CE/1.2.7/HydroCoil

HydroCoil Embolic System, Microvention – Sim&Size v1.2.7 Instructions for Use The HydroCoil Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to …

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DMI/CE/1.2.7/Axium

Axium and Axium Prime Detachable Coils, Medtronic – Sim&Size v1.2.7 Indications for Use AXIUM™ Detachable Coils and AXIUM™ PRIME Detachable Coils are intended for the endovascular embolisation of intracranial aneurysms. AXIUM™ Detachable Coils and AXIUM™ PRIME Detachable Coils are also intended for the embolisation of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous …

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DMI/CE/1.2.7/eCLIPS

eCLIPS, Evasc – Sim&Size v1.2.7 Indications for Use The eCLIPs TM Bifurcation System is indicated for the treatment of intracranial bifurcation aneurysms. LABL-0081 Rev 4.03 – Released: 2022-11-24

DMI/CE/1.2.7/LVISEVO

LVIS EVO, Microvention – Sim&Size v1.2.7 Indications for Use The LVIS EVO Device is intended for use with embolic coils for the treatment of intracranial neurovascular diseases. IFU100066 Rev. B

DMI/CE/1.2.7/LVISJr

LVIS Jr. , Microvention – Sim&Size v1.2.7 Indications for Use The LVIS Jr. device is intended for use with embolic coils for the treatment of intracranial neurovascular diseases. IFU LVIS Jr PD110318B rev 2015-07

DMI/CE/1.2.7/LVIS

LVIS, Microvention – Sim&Size v1.2.7 Indications for Use The LVIS device is intended for use with embolic coils for the treatment of intracranial neurovascular diseases. PD110959 REV 2019-07

DMI/CE/1.2.7/Atlas

Neuroform Atlas, Stryker – Sim&Size v1.2.7 Indications for Use The Neuroform Atlas Stent System is intended to be used with occlusive devices in the treatment of intracranial aneurysms. ATLAS Abrev_DFU_3-10-15_r1b

DMI/CE/1.2.7/Contour

Contour, Cerus Endovascular – Sim&Size v1.2.7 Indications for Use he Contour Neurovascular System™ is indicated for the endovascular embolization of intracranial aneurysms. CC005-03.T OCT 2022