![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » FDA Approves Medtronic’s HeartWare HVAD for Advanced Heart Failure
FDA Approves Medtronic’s HeartWare HVAD for Advanced Heart Failure
![Red_Approved_Stamp.gif](https://www.fdanews.com/ext/resources/test/Drug-Images4/Red_Approved_Stamp.gif?t=1578447203&width=430)
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.
Upcoming Events
-
21Oct