Pipeline™ Vantage Embolization Device With Shield Technology™, Medtronic – Sim&Size V2.0.1

Indication for Use

Pipeline Vantage Embolization Device with Shield Technology (P100018/S034)

The Pipeline™ Vantage 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™ Vantage 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.