Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Group urges FDA to pull Stryker’s Wingspan stent from the market, among other regulatory updates.
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Regulatory News In Brief
Intuitive Surgical responds to FDA investigation of increased adverse event reports. Groups call on FDA to change its Freedom of Information Act policy. More regulatory news.
FDA Narrows Indication For Stryker’s Wingspan Intracranial Stent
Agency restricts use of the device to a select patient population with severe intracranial stenosis and recurrent stroke after reviewing studies indicating the device could actually lead to increased rates of stroke and death.
Neuro Panel: Wingspan Stent’s Probable Benefits No Longer Outweigh Risks
Recent post-market study data leads FDA’s Neurological Devices panel to conclude that the intracranial stent system, which gained humanitarian device exemption approval in 2005, no longer shows probable benefits outweighing the risks.