Letter to the FDA Urging the Agency Not to Grant 510(k) Premarket Clearance for the TriGUARD 3 Cerebral Embolic Protection Device

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Public Citizen urged the Food and Drug Administration (FDA) not to grant 510(k) premarket clearance for the TriGUARD 3 Cerebral Embolic Protection Device, which is intended to minimize the risk of stroke during and after transcatheter aortic valve replacement, because data from clinical trials of the device, and comparisons to its predicate device, fail to provide evidence that TriGUARD 3 has a favorable benefit-risk profile or that it is substantially equivalent to its proposed predicate.

September 10, 2021, response letter from the FDA.

See Public Citizen’s other work on medical devices.