The FDA approved a label change for Abbott's HeartMate 3 heart pump, eliminating aspirin use from patient treatment plans.
The updated label has also been approved by Canadian and European Union regulatory agencies, according to an Aug. 21 news release from Abbott.
The change is based on findings from the ARIES-HM3 study, published Nov. 11 in JAMA, which showed patients who did not use aspirin after receiving a HeartMate 3 device had almost 40% fewer complications compared to patients who did use aspirin.
Aspirin is routinely used as part of a heart patient's blood thinning regimen to reduce the risk of blood clot formation.
Patients who did not use aspirin after receiving a HeartMate 3 implant also experienced fewer days in the hospital, the release said.