Heart failure (HF) is one of the major drivers for the growth of mechanical circulatory support devices (MCSDs). MCSDs are used in three therapies in patients who are currently ineligible for a heart transplant: Bridge to Transplant, Destination, and Bridge to Recovery Therapy. Recently, the FDA announced a Class I recall for Abbott’s HeartMate 3 left ventricular assist device (LVAD)—an MCSD that assists a failing heart to pump oxygenated blood to the rest of the body. The lack of available hearts for transplantation and HeartMate 3’s Class I FDA recall make the current therapy landscape for HF much more dire, says GlobalData, a data and analytics company.
According to GlobalData, there were over 7.8 million prevalent cases of HF in the US alone in 2023, registering a compound annual growth rate (CAGR) of 2 per cent between 2015 and 2023 due to the increasing ageing population.
Joselia Carlos, Senior Medical Device Analyst at GlobalData, comments: “The unfortunate situation is that the number of patients with HF requiring heart transplantation far exceeds the number of available hearts.”
Before Medtronic discontinued its HeartWare LVAD System in 2021 due to a high incidence of neurological adverse events, Abbott possessed about 58 per cent share in the LVAD market, while Medtronic had about 42 per cent. Since then, Abbott consistently has had over 90 per cent of the global market share in the LVAD space.
Carlos continues, “Seeing how the HeartMate 3 device is the main LVAD marketed in the US, the recall could be fatal for patients who need to undergo therapy while they are either waiting for or are deemed ineligible for a heart transplant.”
Interestingly, this is not the first time Abbott’s HeartMate 3 device has received an FDA recall status. Similar to the most recent recall situation, the FDA announced a Class I recall in 2018 for the same device due to the potential occurrence of outflow graft testing occlusions post-implantation, resulting in adverse effects in patients such as low blood flow or clotting. There are few LVAD alternatives currently on the market; however, one promising substitute to the HeartMate 3 is Jarvik Heart’s Jarvik 2000.
“While monopolising a market is beneficial for any company, dire situations such as the increasing prevalence of HF warrant the need for other options regarding LVADs. The Jarvik 200 is currently being used by leading hospitals in the US as a Bridge to Transplant Therapy for clinical trials,” concludes Carlos.
Edits made by EH News Bureau