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."

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