FDA Approves Medtronic’s HeartWare HVAD for Advanced Heart Failure

October 2, 2017

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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