Posts Tagged ‘LVAS’

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March 5th, 2014

4 Deaths Linked to Thoratec HeartMate II LVAS

Thoratec Corporation on Tuesday issued an urgent safety advisory about a serious problem with a key component of the HeartMate II LVAS system. The company said four patients had died and five 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 […]


November 21st, 2012

HeartWare LVAD Approved By FDA For Transplant Patients

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 ADVANCE trial, in which 140 […]