The US Food and Drug Administration (FDA) has announced a Class I recall, the most serious designation, for Abbott’s HeartMate 3 left ventricular assist device (LVAD) – a mechanical circulatory support device that is used to assist a failing heart to pump oxygenated blood to the rest of the body.
This LVAD has been associated with 81 incidents of blood leakage or unwanted airflow, including 70 injuries and two deaths.
The HeartMate 3 device is widely used as a therapy option in patients with heart failure (HF) who are either waiting for or are deemed ineligible for a heart 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.
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The unfortunate current situation is that the number of patients with HF requiring heart transplantation far exceeds the number of available hearts.
In 2023, in the US alone, there were more than 7.8 million prevalent cases of HF due to an increasing ageing population, growing at a compound annual growth rate of 2% between 2015 and 2023.
The lack of available hearts for transplantation, in combination with HeartMate 3’s Class I FDA recall, makes the current therapy landscape for HF much more dire.
While monopolising a market is beneficial for any company, fatal situations such as an increasing prevalence of HF and a shortage of available hearts for transplantation warrant the need for other LVAD options.
A promising alternative to HeartMate 3 is Jarvik Heart’s Jarvik 2000. It is currently being used by leading US hospitals as a therapy option in clinical trials.
Interestingly, this is not the first time Abbott’s HeartMate 3 device has received an FDA recall status.
In 2018, the FDA announced a Class I recall for the same device due to the potential occurrence of outflow graft twisting occlusions post-implantation, resulting in adverse events such as low blood flow or clotting.