FDA Approves HeartMate 3 as Destination Therapy in Advanced HF

The approval is based on the MOMENTUM 3 study, which showed lower rates of reoperation for pump malfunction with the newly designed LVAD.

FDA Approves HeartMate 3 as Destination Therapy in Advanced HF

The US Food and Drug Administration (FDA) has approved HeartMate 3, a continuous-flow left ventricular assist device, for patients with advanced heart failure ineligible for heart transplantation, Abbott announced today.

The HeartMate 3 device uses a frictionless, magnetically levitated, centrifugal-flow pump and is designed to minimize the risk of pump thrombosis. In the MOMENTUM 3 study, HeartMate 3 was associated with a lower rate of reoperation for pump malfunction at 2 years compared with HeartMate 2, an LVAD that uses an axial-flow pump.  

The HeartMate 3 is already approved as a bridge to heart transplantation, as is the HeartMate 2. But one of the drawbacks of the prior model as well as devices from other manufacturers is the higher risk of pump malfunction, caused primarily by pump thrombosis when used as destination therapy. Abbott says the design changes with the HeartMate 3 are intended to reduce trauma to the blood passing through the pump while improving flow.  

The MOMENTUM 3 study was published earlier this year in the New England Journal of Medicine and reported by TCTMD. HeartMate 3 is approved in Europe as both as bridge to transplantation and as destination therapy.

Photo Credit: Abbott

Michael O’Riordan is the Managing Editor for TCTMD. He completed his undergraduate degrees at Queen’s University in Kingston, ON, and…

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