Abbott‘s HeartMate 3 left ventricular assist device (LVAD) won FDA approval to be used as a destination therapy for advanced heart failure patients who are not eligible for a transplant. Previously, the device has been indicated for patients eligible for and waiting for a transplant.
Since transplant hearts are rarely available and not all patients are healthy enough to receive one, the HeartMate 3 can help the native heart pump blood throughout the body for the rest of the patients’ lives.
“Approximately a quarter of a million people are living with advanced heart failure, and many of these people will need a heart transplant; however, only a few thousand will receive a new heart,” said Nir Uriel, M.D., director of Heart Failure, Transplant and Mechanical Circulatory Support at the University of Chicago Medicine. “The destination therapy approval for Abbott’s HeartMate 3 device now gives these patients new hope that they can receive a heart pump clinically proven to mitigate challenges we’ve historically confronted with this therapy—stroke and blood clotting—while also offering survival rates on par with transplant.”
The HeartMate 3 has a fully levitated mechanism that doesn’t create much turbulence, helping to address the issue of clotting and the potential for stroke that is a risk with many previously developed heart pumps.
The HeartMate II, at that time under the Thoratec name, received a similar approval back in 2010.
Some details, according to Abbott, about the MOMENTUM 3 study that led to the approval:
During the study, patients with the HeartMate 3 LVAD had an unprecedented survival rate of 82.8 percent at two years. Furthermore, rates of suspected pump thrombosis (clotting of blood) remained very low at 1.1 percent at two years. The study also showcased the lowest-ever published stroke rate (10 percent) for a continuous-flow LVAD at two years.
The MOMENTUM 3 study included more than 1,000 patients with New York Heart Association (NYHA) Class IIIB or IV heart failure. Patients were followed for a short-term endpoint of six months and a long-term endpoint of two years.
Product page: HeartMate 3 LVAD…