Thoratec HeartMate A Good Choice For The Very Sick Despite Risks – Panel
This article was originally published in The Gray Sheet
Executive Summary
Thoratec's HeartMate VE left-ventricular assist system (LVAS) should be made available to end-stage heart failure patients ineligible for a transplant, even though 94% of patients treated with the LVAS in clinical trials experienced a serious adverse event, FDA's Circulatory System Devices Panel agreed
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