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FDA Asks Experts For Advice On Aneurysm Flow Diverter Clinical Trials

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.

FDA will ask its Neurological Devices Panel to recommend appropriate follow-up timelines for clinical trials for stent-assisted coils and flow diverters when the experts meet April 17 at the agency's White Oak Campus. The agency will also have other critical questions for the panel as it looks to better understand the new devices to treat brain aneurysms and develop guidelines for future trials and PMA applications. (See Also see "FDA Panel To Weigh In On Neuro Flow Diverter Device Studies" - Medtech Insight, 24 February, 2015..)

"The safety and effectiveness for novel interventional aneurysm treatments is an evolving, innovative product area that involves several factors including aneurysm type (small/medium versus larger/giant), location (anterior versus posterior) and surrounding anatomy (such as perforators), different assessment tools (primary and secondary endpoints), and different clinical trial designs (single arm studies using performance goals or randomized controlled trials)," the agency notes

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