Pipeline Flex Embolization Device
Aneurysm Flow Diversion
Aneurysm Flow Diversion
The clinically proven¹ Pipeline™ Flex device redefines treatment for large or giant wide-necked intracranial aneurysms by diverting flow away from the aneurysm neck, reconstructing the parent artery and restoring its natural course.2,3
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 technical features of the Pipeline embolization device support a safe and highly effective procedure.2
View an animation of aneurysm flow diversion with the Pipeline Flex embolization device.
The PUFs study was a multi-center, prospective, interventional, single-arm trial to evaluate the safety and effectiveness of the Pipeline implant in the treatment of complex intracranial aneurysms.
PUFs studied 108 patients with a wide-necked, large, or giant intracranial aneurysm in the petrous, cavernous, or paraophthalmic regions of the internal carotid artery.
See the Neurovascular Product Catalog for information about these related products.
Pipeline Flex Embolization Device Instructions for Use
This technical manual includes indications, warnings, precautions, device sizes, instructions, MRI information, and clinical study summary. Find in the product labeling supplied with each device or call Medtronic at 800-961-9055.
The PUFS study only included the Pipeline embolization device. The Pipeline Flex embolization device contains the same implant as the Pipeline embolization device.
Medtronic Internal Report FD3456B, PUFS 5 Year CSR
Becske T. et al., Pipeline for Uncoilable or Failed Aneurysms. Results from a Multicenter Clinical Trial. Radiology. Published online Feb 15, 2013
Kallmes, DF et al. International Retrospective Study of the Pipeline Embolization Device: A Multicenter Aneurysm Treatment Study, AJNR Published online, Oct 29, 2014
Medtronic Internal Report TR-NV10931/TR-NV11121
Kallmes DF, Ding YH, Dai D, Kadirvel R, Lewis DA, Cloft HJ. A second-generation, endoluminal, flow-disrupting device for treatment of saccular aneurysms. AJNR AmJ Neuroradiol. 2009;30(6):1153-1158.
Medtronic Internal Report TR-NV11534/TR-NV11121.