Your browser is out of date
With an updated browser, you will have a better Medtronic website experience. Update my browser now.
Aneurysm flow diversion is a minimally invasive treatment in which a device known as a neurovascular stent placed in the parent blood vessel of a brain aneurysm may divert blood flow away from the aneurysm. Over time, blood flow into the aneurysm may slow down, eventually ceasing to enter the aneurysm altogether. As the body’s natural healing process works with the flow diversion device, the blood vessel may heal, and the aneurysm may shrink.1-4
The Pipeline™ device is designed to divert blood flow away from brain aneurysms in certain segments of the internal carotid artery (ICA). The device features a braided cylindrical mesh tube that is implanted across the base or neck of the aneurysm. The device decreases blood flow to the aneurysm, reconstructing the diseased section of the parent vessel. This may result in the aneurysm shrinking in size or resolving over time. Shield Technology™ builds on the clinically proven Pipeline™ Flex embolization device by introducing an innovative surface modification. The Pipeline™ device is the first flow diversion device approved by the FDA.1,3,5
Blood flows freely into the aneurysm.
After treatment with the Pipeline™ device, blood flow into the aneurysm slows. Over time, blood may no longer flow into the aneurysm.
As the body’s natural healing process works with the Pipeline™ device, the aneurysm may shrink.3
The Pipeline™ device has been shown to be effective at treating small, medium, large, or giant wide-necked aneurysms, located in specific segments of the internal carotid artery.*2,4
Potential complications include (but are not limited to)1:
Your physician may require medications such as (but not limited to) aspirin and Clopidogrel™† before and after treatment. Persons with known allergy to cobalt/chromium alloy (including major elements of cobalt, chromium, nickel, molybdenum, or tungsten) may suffer an allergic reaction to the Pipeline™ device.
Check with your doctor for a complete list of potential complications.
Traditional methods may be insufficient to treat certain challenging aneurysms. Long-term care of these aneurysms can be difficult.8
Talk to your doctor to decide which treatment option may be best for you. Treatment with these devices are prescribed by your physician. These treatments are not for everyone. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of these treatments, results may vary.
Another important treatment option available to patients is medical management. Many aneurysms may not require intervention.
Learn what to expect before, during, and after the flow diversion procedure.
As outlined in PUFs and PREMIER trial results.
Please discuss all risks and warnings with your doctor.
Pipeline™ embolization device is no longer commercially distributed.
M002318CDOC2_B-Pipeline Flex with Shield Technology IFU
Becske, T. et al. Long-term clinical and Angiographic outcomes following Pipeline Embolization Device treatment of complex internal carotid artery aneurysms: Five-year results of the Pipeline for uncoilable or failed aneurysms trial. www.neurosurgery-online.com. Volume 80. January 2017.
Szikora I, Marosfoi M, Salomváry B, Berentei Z, Gubucz I. Resolution of mass effect and compression symptoms following endoluminal flow diversion for the treatment of intracranial aneurysms. AJNR Am J Neuroradiol 2013;34:935-9.
Hanel RA, Kallmes DF, Lopes DK, et al. Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results. Journal of NeuroInterventionalSurgery 2020;12:62-66.
Kallmes, DF et al. International Retrospective Study of the Pipeline Embolization Device: A Multicenter Aneurysm Treatment Study, AJNR Published online, Oct 29, 2014.
Brain Aneurysm Foundation. Understanding: Brain Aneurysm Statistics and Facts. Retrieved September 15, 2015, from: http://www.bafound.org/Statistics_and_Facts
https://www.bafound.org/about-brain-aneurysms/%20brain-aneurysm-basics/warning-signs-symptoms/. Last accessed March 2022.
Seibert, Brad et al. “Intracranial aneurysms: review of current treatment options and outcomes.” Frontiers in neurology vol. 2 45. 8 Jul. 2011, doi:10.3389/fneur.2011.00045