Abbott claimed new late-breaking Clinical Trial data from the MOMENTUM 3 clinical study which is the largest left ventricular assist device (LVAD) trial in the world to evaluate patients in need of both short-term and long-term support in a single study. The data was published online in The New England Journal of Medicine. .
Mandeep R. Mehra, M.D., medical director of Brigham and Women’s Hospital Heart and Vascular Center in Boston said “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 U.S Food and Drug Administration to advocate consideration of a long-term ( destination therapy) indication for Abbott’s HeartMate II LVAD in treating advanced heart failure.
The HeartMate II is the most widely used LVAD in the world for long-term support. More than 1,000 patients with New York Heart Association (NYHA) Class IIIB or IV heart failure participated in the study. Patients were followed for a short-term endpoint of six months and a long-term endpoint of two years.
patients receiving HeartMate 3 LVAD had significant improvements compared to the HeartMate II LVAD in functional capacity and quality of life scores at two years compared to baseline. Rates of all other adverse events were similar between the HeartMate 3 LVAD and historical rates seen in the HeartMate II LVAD, which is the most widely used and extensively studied LVAD commercially available.
The MOMENTUM 3 Investigation Device Exemption (IDE) study is a prospective, multi-center, randomized, unblinded study evaluating the safety and effectiveness of the HeartMate 3 LVAD when used for the treatment of advanced, refractory, left ventricular heart failure. This study included all-comers, which means researchers evaluated the device regardless of whether the patient needed a short-term support option while awaiting transplantation or a long-term support option for those who are not candidates for cardiac transplantation.