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Home » HeartWare VAS Gets Panel Nod Despite Safety, Data Concerns
HeartWare VAS Gets Panel Nod Despite Safety, Data Concerns
April 27, 2012
By a lopsided vote, the FDA’s Circulatory System Devices Panel Wednesday recommended approval of the HeartWare Ventricular Assist System (HVAS), in what could be an early sign of more tolerance by FDA reviewers toward study designs other than traditional double-blind clinical trials.