Public Citizen Urges FDA to Take Action for Sale of Misbranded Brain Stent Device
April 3, 2014
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Public Citizen is urging the Food and Drug Administration (FDA) to take action against Stryker Neurovascular and Boston Scientific for publishing false and misleading information on their websites regarding Wingspan Stent System devices, medical devices used to prop open narrowed blood vessels in the brains of certain types of stroke patients. The websites falsely expands the FDA-approved use of the device and also fail to report information from a critically important study that found dangers for patients using the device.
April 15, 2014, Response Letter from the FDA