ABOUT THE THERAPY ANEURYSM FLOW DIVERSION

   Important Safety Information

ANEURYSM FLOW DIVERSION

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

FLOW DIVERSION WITH THE PIPELINE FLEX EMBOLIZATION DEVICE

The Pipeline™ Flex embolization 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. Pipeline is the first flow diversion device approved by the FDA.1, 3, 5

BEFORE FLOW DIVERSION

Illustration of brain aneurysm before flow diversion

Blood flows freely into the aneurysm.

FLOW DIVERSION TECHNIQUE

Illustration of the flow diversion technique for treating brain aneurysm

After treatment with Pipeline Flex, blood flow into the aneurysm slows. Over time, blood may no longer flow into the aneurysm.

AFTER FLOW DIVERSION

Illustration of brain aneurysm after it has been treated with flow diversion

As the body’s natural healing process works with the Pipeline Flex stent implant, the aneurysm may shrink.3

BENEFITS AND RISKS

The Pipeline Flex embolization 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

  • Death
  • Transient and permanent neurological deficits including stroke and transient ischemic attack (TIA), intra- and extra-cranial bleeding
  • Vascular injuries including vasospasms and perforation
  • Device deformation, fracture, and migration
  • Complications of using contrast media and anticoagulant, antiplatelet medications
  • Infections

Find a complete list of indications and safety warnings.

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 Flex embolization device.

Check with your doctor for a complete list of potential complications. 

TRADITIONAL BRAIN ANEURYSM TREATMENT OPTIONS

Other treatment methods for cerebral or brain aneurysm include no treatment, surgical clipping, endovascular embolization, or observation (non-intervention).6,7 

INVASIVE SURGICAL CLIPPING

  • Surgical procedure requiring an opening of the skull or a craniotomy 
  • Placement of a clip on the neck of the aneurysm to prevent blood flow into the aneurysm
Illustration of surgical clipping treatment for brain aneurysm.

ENDOVASCULAR COIL EMBOLIZATION

  • Minimally invasive approach through a small incision in the leg
  • Placement of embolic coils or liquids into aneurysm to prevent blood flow into aneurysm
Illustration of endovascular embolization treatment for brain aneurysm.

Traditional methods may be insufficient to treat challenging certain aneurysms. Long-term care of these aneurysms can thus be difficult.8

GETTING FLOW DIVERSION

Learn what to expect before, during, and after the flow diversion procedure.

READ MORE

PIPELINE FLEX BROCHURE

Download the brochure in your preferred language:

*

As outlined in PUFs and PREMIER trial results.

†

Please discuss all risks and warnings with your doctor.

1

Pipeline™ Flex Embolization Device IFU

2

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. 

3

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.

4

PREMIER Clinical Study Report Medtronic FD3563 Rev B. 12-SEP-2018

5

Kallmes, DF et al. International Retrospective Study of the Pipeline Embolization Device: A Multicenter Aneurysm Treatment Study, AJNR Published online, Oct 29, 2014.

6

Brain Aneurysm Foundation. Understanding: Brain Aneurysm Statistics and Facts. Retrieved September 15, 2015, from: http://www.bafound.org/Statistics_and_Facts

7

http://www.bafound.org/about-brain-aneurysms/ brain-aneurysm-basics/warning-signs-symptoms/

8

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