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TriGUARD 3 Data Does Not Pass Muster: FDA Experts

The panel of experts said the clinical trial data is insufficient for Keystone Heart’s TriGUARD 3, and the little data there is shows use of the cerebral embolic protection device increases risk for stroke and 30-day mortality.

Keystone Heart's TriGUARD 3 limited trial data showed serious safety concerns
• Source: Keystone Heart

Keystone Heart’s TriGUARD 3 cerebral embolic protection device got a clear thumbs-down from a panel of US Food and Drug Administration experts. The panelists were asked whether the data provided by the company on the safety and efficacy of the product showed it worked.

The FDA on 3 August convened its Circulatory System Devices Advisory Panel to review a 510(k) application of the...

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