HeartWare International, a provider of less invasive, miniaturised circulatory support medacal devices for advanced heart failure, has received US Food and Drug Administration (FDA) approval for an investigational device exemption (IDE) supplement to enroll a second allotment of 54 patients in its ‘Advance’ bridge-to-transplant clinical trial under a continued access protocol (CAP).

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FDA approves second patient allotment to HeartWare Advance clinical trial