Recall of Artificial Heart Devices for Heart Transplant by FDA

Heart failure (HF) is a significant factor driving the growth of mechanical circulatory support devices (MCSDs), which are used in three therapies for patients not eligible for heart transplants: Bridge to Transplant, Destination, and Bridge to Recovery Therapy (1^✔ ✔Trusted Source
HeartMate 3 recall and inadequate hearts for transplantation make HF therapy landscape much more dire, says GlobalData

Go to source). Recently, the FDA announced a Class I recall for Abbott’s HeartMate 3 left ventricular assist device (LVAD), an MCSD that helps a failing heart pump oxygenated blood throughout the body. The shortage of hearts for transplantation and the HeartMate 3’s recall highlight the increasingly dire HF therapy landscape, according to GlobalData, a leading data and analytics company.

Joselia Carlos, Senior Medical Device Analyst at GlobalData, states: "The unfortunate reality is that the number of HF patients needing heart transplants far exceeds the available hearts."

Abbott’s Market Dominance in LVADs Post-2021

Before Medtronic discontinued its HeartWare LVAD System in 2021 due to high neurological adverse event rates, Abbott held about 58% of the LVAD market, with Medtronic at 42%. Since then, Abbott has maintained over 90% of the global LVAD market share.

Carlos adds: "As the primary LVAD marketed in the US, the HeartMate 3 recall could be devastating for patients awaiting or ineligible for heart transplants."

Notably, this is not the first FDA recall for Abbott’s HeartMate 3. In 2018, a Class I recall was issued due to outflow graft testing occlusions post-implantation, leading to adverse effects like low blood flow or clotting. While LVAD alternatives are few, one promising substitute is Jarvik Heart’s Jarvik 2000.

Carlos concludes: "While market dominance benefits a company, the rising prevalence of HF underscores the need for more LVAD options. The Jarvik 2000 is currently being used in US hospitals for Bridge to Transplant Therapy in clinical trials."

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Reference:

1. HeartMate 3 recall and inadequate hearts for transplantation make HF therapy landscape much more dire, says GlobalData - (https://www.globaldata.com/media/medical-devices/heartmate-3-recall-inadequate-hearts-transplantation-make-hf-therapy-landscape-much-dire-says-globaldata/)

Source-Medindia