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Medical Devices / Submissions and Approvals

FDA Approves Medtronic’s HeartWare HVAD for Advanced Heart Failure

Oct. 3, 2017
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Medtronic received FDA approval for its HeartWare HVAD System for patients with advanced heart failure who are not candidates for heart transplants.

The HVAD System, a left ventricular assist device or LVAD, helps the heart pump and increases the amount of blood that flows through the body.

The HVAD System received FDA approval in 2012 as a bridge to transplant in patients eligible for heart transplants.

It also received European CE Mark that same year for patients at risk of death from refractory, end-stage heart failure, and it previously had received CE Mark for the bridge to transplant indication in 2009.

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