The FDA label expansion decision was supported by the data from the ARIES-HM3 trial that showed aspirin avoidance did not increase the risk of bleeding in patients with Abbott’s HeartMate 3 left ventricular assist device. Image credit: Poetra.RH / Shutterstock.

The US Food and Drug Administration (FDA) has approved a label change for Abbott’s HeartMate 3 left ventricular assist device, eliminating the need for aspirin use as part of routine patient management.

The label update is exclusive for patients with an Abbott HeartMate 3 heart pump. Canadian and European regulatory bodies have also approved the label update.

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Aspirin and other blood thinners are commonly used with left ventricular assist devices to reduce the risk of blood clots associated with heart pumps. The approval for eliminating aspirin from the blood-thinning regimen for HeartMate 3 was supported by the data from the ARIES-HM3 trial (NCT04069156).

The study enrolled 600 patients using HeartMate 3 pumps. The study showed non-inferiority in event-free survival in the patients receiving the standard post-implant vitamin-K antagonist (VKA) treatment regimen without the addition of aspirin and those who received aspirin.

The trial also found that aspirin avoidance was associated with reduced nonsurgical bleeding events. The patients who did not receive aspirin had 40% fewer complications from bleeding without increasing the risk of forming a blood clot than patients who also received a HeartMate 3 but did take aspirin. Aspirin avoidance also reduced a patient’s hospital stay by 47%.

GlobalData predicts the cardiovascular medical device market will reach $86.5bn by 2030. The left ventricular assist device market will reach $2.24bn by 2033. Abbott’s HeartMate 3 is the current market leader in the field.

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However, the company has faced setbacks in recent months. In May, Abbott had to issue a Class I recall for the HeartMate 3 device after multiple reports of injuries and two deaths. The product correction was issued after the FDA identified issues with the seal interface between the LVAD inflow cannula and the apical cuff. The seal break allows for blood or air to enter the device, which can result in bleeding, right heart failure, longer-than-expected surgery, or an air embolism.