Stroke Devices: Neurointerventional Solutions Gain Momentum
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.
You may also be interested in...
The agency scheduled a Neurological Devices Panel meeting for March 1 to consider appropriate clinical design and data expectations for intracranial aneurysm devices.
FDA's Neurological Devices Panel says sponsors should be required to conduct randomized controlled trials for aneurysm treatment devices such as flow diverters and should only be allowed to use performance goal studies as a last resort to support approval.
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.