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Experts Recommend Requiring Randomized Trials For Flow Diverter PMAs

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.

Randomized clinical trials for evaluating flow diverters intended to treat brain aneurysms are a difficult due to recruitment and ethical challenges, but FDA should still require randomized trials to support approval, according to a panel of its experts.

Multiple flow diverters are coming through the development pipeline. (See Also see "Stroke Devices: Neurointerventional Solutions Gain Momentum" - In Vivo, 30 May, 2014.

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