FDA Neurological Devices Panel to Review Flow Diverter Technology

April 7, 2015—The Center for Devices and Radiological Health of the US Food and Drug Administration (FDA) announced the agenda for a meeting to review flow diverter technology. The Neurological Devices Panel of the Medical Devices Advisory Committee will meet on April 17 from 8:00 AM to 4:00 PM in the Great Room (#1503) of Building 31 on the FDA’s White Oaks Campus at 10903 New Hampshire Avenue in Silver Spring, Maryland. The agency welcomes the attendance of the public. The link for the FDA webcast of the meeting is https://collaboration.fda.gov/ndpm0415/.

According to the FDA, the committee will discuss the current knowledge regarding the conduct of clinical studies and evaluation of clinical study data for flow diverter technology as an endoluminal treatment option for intracranial aneurysms. The FDA is convening this committee to seek expert opinion on scientific and clinical considerations relating to the study design and existing clinical studies for flow diverter technology indicated for the neurovasculature.

The agency intends to make background material available to the public no later than 2 business days before the meeting, at the location of the advisory committee meeting, and on the FDA's website after the meeting. Background material will be available on the FDA website. More preliminary information about the meeting is available here.