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DMI/FDA/1.2.6/LVIS EVO

Low-Profile Visualized Intraluminal Support (LVIS) EVO., Microvention – Sim&Size v1.2.6   Under Clinical Trail The purpose of this study is to assess the safety and effectiveness of the Low-Profile Visualized Intraluminal Support (LVIS) EVO in the treatment of intracranial aneurysms within the intended indication for use.    

DMI/FDA/1.1.2/LVISJr

Low-Profile Visualized Intraluminal Support (LVIS) Jr., Microvention – Sim&Size v1.1.2 Indication for use (P170013) The LVIS Jr. is indicated for use with neurovascular embolization coils in patients  18 years of age for the treatment of wide-neck (neck width  4 mm or dome to neck ratio < 2) saccular intracranial aneurysms arising from a parent vessel …

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DMI/FDA/1.1.2/LVIS

Low-Profile Visualized Intraluminal Support (LVIS), Microvention – Sim&Size v1.1.2 Indication for use (P170013) The LVIS is indicated for use with neurovascular embolization coils in patients  18 years of age for the treatment of wide-neck (neck width  4 mm or dome to neck ratio < 2) saccular intracranial aneurysms arising from a parent vessel with a …

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DMI/FDA/1.1.2/Atlas

Neuroform Atlas Stent System, Stryker – Sim&Size v1.1.2 Indication for use (P180031) The Neuroform Atlas Stent System is indicated for use with neurovascular embolization coils in the anterior and posterior circulation of the neurovasculature for the endovascular treatment of patients 18 years of age with saccular wide-necked (neck width  4 mm or a dome-to-neck ratio …

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DMI/FDA/1.1.2/Web

Woven EndoBridge (WEB) Aneurysm Embolization System – Sim&Size v1.1.2 Indication for use (P170032) The WEB Aneurysm Embolization System is indicated for use at the middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA) terminus, anterior communicating artery (AComm) complex, or basilar artery apex for the endovascular treatment of adult patients with saccular, wide neck, bifurcation …

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DMI/FDA/1.1.2/Evolve

Surpass Evolve Flow Diverter, Stryker – Sim&Size v1.1.2 Indication for use (P170024/S003) The Surpass Evolve Flow Diverter System is indicated for use in the endovascular treatment of patients (18 years of age and older) with unruptured large or giant saccular wide-neck (neck width  4 mm or dome-to-neck ratio < 2) or fusiform intracranial aneurysms in …

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DMI/FDA/1.1.2/FREDX

Flow Re-Direction Endoluminal Device X, MicroVention – Sim&Size v1.1.2 Indication for use (P180027/S002) The Flow Re-Direction Endoluminal Device (FRED) System is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment of adult patients (22 years of age or older) with wide-necked (neck width 4 mm …

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DMI/FDA/1.1.2/FRED

Flow Re-Direction Endoluminal Device, MicroVention – Sim&Size v1.1.2 Indication for use (P180027) The Flow Re-Direction Endoluminal Device (FRED) System is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment of adult patients (22 years of age or older) with wide-necked (neck width 4 mm or …

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DMI/FDA/1.1.2/Vantage

Pipeline™ Vantage Embolization Device with Shield Technology™, Medtronic – Sim&Size v1.1.2 Under Clinical Trail : The purpose of this study is to assess the safety and effectiveness of the Pipeline™ Vantage Embolization Device with Shield Technology™ in the treatment of intracranial aneurysms within the intended indication for use. Indication for Use The Pipeline™ Vantage Embolization …

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DMI/FDA/1.1.2/PEDSHIELD

Pipeline Flex with Shield Technology, Medtronic – Sim&Size v1.1.2 Indication for use (P100018/S026) The Pipeline™ Flex Embolization Device with Shield Technology 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 …

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