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Home » HeartWare VAS Panel Nod Could Pave Way for Unorthodox Trial Designs
HeartWare VAS Panel Nod Could Pave Way for Unorthodox Trial Designs
May 9, 2012
By a lopsided vote, the FDA’s Circulatory System Devices Panel April 25 recommended approval of the HeartWare Ventricular Assist System (HVAS), in what could be an early sign of more tolerance by advisory committees toward study designs other than traditional double-blind clinical trials.