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News From the Food and Drug Administration
June 19, 2018

Neurovascular Stent Caution

JAMA. 2018;319(23):2372. doi:10.1001/jama.2018.7721

The FDA has offered safety recommendations regarding neurovascular stents used in stent-assisted coiling (SAC) of wide-neck intracranial aneurysms. Agency officials said the FDA has received reports of strokes and deaths in the treatment of unruptured brain aneurysm that may be related to how the device was used or to patient characteristics.

Stent-assisted coiling packs the aneurysm with thin wire coils that cause a thrombus to form, closing the aneurysm off from blood flow and potential rupture. A stent placed in the blood vessel at the base of the aneurysm keeps the coils from migrating and supports the vessel.

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