FDA Panel To Weigh In On Neuro Flow Diverter Device Studies
This article was originally published in The Gray Sheet
The agency's Neurological Devices Panel will provide recommendations on study design and data analysis issues for flow diverter devices for aneurysms in April.
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With the explosion of new interventional aneurysm devices under development, especially flow diverters, the agency asks its Neurological Devices Panel to discuss appropriate trial designs, patient follow-up and other study details for this device category during an April 17 meeting.
The firm hopes to support approval for use of the embolization device for smaller aneurysms and in more anatomical locations with data from its just-launched PREMIER trial. Also, Covidien announced the first patient in a new registry to track postmarket data, and hopefully support reimbursement, for its mechanical thrombectomy stroke devices including Solitaire 2.
At this year’s International Stroke Conference, manufacturers offered a glimpse of new and emerging technologies for both ischemic and hemorrhagic stroke. These neurointerventional devices are gaining momentum and driving growth in the market for stroke products, a largely un-penetrated market valued at more than $1 billion worldwide.