Abbott announces new long-term data for HeartMate 3 heart pump
Abbott announced new clinical trial data from the Momentum 3 clinical study, what is calls the largest left ventricular assist device trial in the world to evaluate patients in need of both short-term and long-term support in a single study. The data were published online in The New England Journal of Medicine and presented during a late-breaking session at the American College of Cardiology's Scientific Session. "The long-term data for the pivotal MOMENTUM 3 trial demonstrate overall survival of 83 percent at 2-years and marked improvement in clinical outcomes for our patients suffering with advanced heart failure," said Mandeep R. Mehra, M.D., medical director of Brigham and Women's Hospital Heart and Vascular Center in Boston. "We have seen greater pump durability-mostly driven by an absence of confirmed pump thrombosis-as well as a significantly lowered stroke rate without an increase in other adverse events." The Momentum 3 study data-which will be submitted to the FDA to support consideration of a long-term indication for Abbott's HeartMate 3 LVAD-compared the HeartMate 3 LVAD to the HeartMate II LVAD in treating advanced heart failure, the company said. The long-term cohort met its primary endpoint with 77.9% event free survival, showing superiority over the HeartMate II LVAD at 56.4%. Patients with the HeartMate 3 LVAD had a survival rate of 82.8% at two years compared to 76.2% for those with the HeartMate II LVAD. Rates remained at 1.2% suspected thrombosis for the HeartMate 3 LVAD, with no reoperations, pump replacements or urgent transplants occurring at two years. Stroke rate lower by 10% for the HeartMate 3 LVAD compared to the HeartMate II LVAD at 19, Abbott added.