Pipeline Flex Embolisation Device With Shield Technology, Medtronic – Sim&Size V2.0.1

Indications for Use

Pipeline Flex Embolization Device (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 embolization device is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width ≥ 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm. 

Pipeline Flex with Shield Technology (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 segments. The Pipeline™ Flex embolization device with Shield Technology is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysm (IAs)arising from a parent vessel with a diameter 2.0 mm and ≤ 5.0 mm.