FDA approves label expansion for Abbott HeartMate 3 LVAD to remove aspirin from treatment regimen

Abbott (NYSE: ABT)+ announced today that the FDA approved a label change for its HeartMate 3 left ventricular assist device (LVAD).

The label expansion eliminates aspirin as part of routine patient management. This update exclusively applies to patients with a HeartMate 3 pump and also has Canadian and European approval.

HeartMate 3 helps the heart pump blood when it fails to pump blood effectively on its own. The devices work by mimicking the pumping function of the heart’s left ventricle. The devices divert blood from the weakened left ventricle and propel it into the body’s main artery to help circulate blood throughout the body.

Historically, patients receiving LVADs used blood thinners to reduce the risk of blood clots associated with the implant. The ARIES-HM3 study demonstrated that patients who received Abbott’s pump but didn’t take aspirin as part of their blood-thinning medication regimen had nearly 40% fewer complications from bleeding without increasing the risk of forming a blood clot compared to those who received the HeartMate 3 but did take the aspirin.

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