Heart pump recall, lack of donor organs create concern for heart failure patients

Editor's Note

The lack of available hearts for transplantation combined with the recent recall of Abbott’s HeartMate 3 left ventricular assist device (LVAD) “makes the current therapy landscape for heart failure much more dire,” according to a May 20 report in Medical Device Network.

The recall of the device, which is used to help failing hearts pump oxygenated blood, was deemed class 1 by the US Food and Drug Administration (FDA)—the most serious classification, indicating risk of serious injury or death. So far, 70 injuries and 2 deaths have been reported among 81 total incidents of blood leakage or unwanted airflow.

According to the article, the LVAD is widely used in heart failure patients who are either waiting or ineligible for a transplant. Prior to 2021, shares in the LVAD market were more or less evenly split between Abbott and Medtronic. However, in May 2021, Medtronic discontinued its HeartWare LVAD System due to a high incidence of neurological adverse events. Since then, Abbott has consistently had more than a 90% share of the market, dominating the LVAD space.

Meanwhile, viable donor hearts are scarce, and heart failure is becoming more common among the aging US population, reportedly growing at a compound annual growth rate of 2% between 2015 and 2023. “A promising alternative to HeartMate 3 is Jarvik Heart’s Jarvik 2000,” Medical Device Network reports. “It is currently being used by leading US hospitals as a therapy option in clinical trials.”