FDA Asks Experts For Advice On Aneurysm Flow Diverter Clinical Trials
This article was originally published in The Gray Sheet
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.
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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.
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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