4 Deaths Linked To Thoratec Heart System

Thoratec Corporation today issued an urgent safety advisory about a serious problem with a key component of the HeartMate II LVAS system. The company said 4 patients had died and 5 patients had a loss of consciousness or other symptoms of hypoperfusion. The episodes occurred when patients and caregivers “experienced difficulties with the process of changing from a primary…

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Physicians Report Alarming Increase In LVAD Pump Thrombosis

Physicians from three top institutions report an abrupt and highly troubling increase over the last two years in the incidence of pump thrombosis in patients who have received the HeartMate II left ventricular assist device (LVAD) manufactured by Thoractec. The current investigation, published online in the New England Journal of Medicine, was initially prompted by an observed increase in…

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HeartWare LVAD Approved By FDA For Transplant Patients

heartware

The FDA said today that it had granted approval to the HeartWare Ventricular Assist System for use in heart failure patients waiting for a transplant. Approval of the device had been expected after the FDA’s Circulatory System Devices panel recommended approval of the device earlier this year. HeartWare was approved based on data from the pivotal…

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FDA Advisory Panel Gives Green Light To HeartWare Ventricular Assist System

HeartWare

The FDA’s Circulatory System Devices panel voted 9-2 on Wednesday to recommend approval of the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure. The panel agreed unanimously (11-0) that the new device is effective. The panel was more divided about safety but ultimately voted  8-3 that the device…

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