Abbott Laboratories’ HeartMate 3 Left Ventricular Assist Device (LVAD) has received FDA approval as a destination therapy for people living with advanced heart failure. The approval allows doctors to offer the HeartMate 3 system to patients with advanced heart failure not eligible for a transplant.
About 5.7 million adults in the United States have heart failure, according to CDC, and around 915,000 new cases of heart failure are diagnosed annually. About half of people who develop heart failure die within 5 years of diagnosis.
For advanced heart failure patients who can’t depend on earlier stage treatment options, LVAD’s take the workload off a weakened heart by pumping blood through the body – providing crucial, life-saving support for patients awaiting a heart transplant or for those not able to receive one.
“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 system sets a new standard in LVAD treatment, reducing the size of the system while reimagining how blood passes through a heart pump. The HeartMate 3 pump utilizes technology known as Full MagLev™ (fully magnetically-levitated) Flow, which reduces trauma to the blood passing through the pump while improving flow, said a press release.
“We partner with physicians to holistically develop therapies that benefit patients and achieve better outcomes,” said Mike Pederson, senior vice president of Abbott’s Cardiac Arrhythmias and Heart Failure business. “The unique design of the HeartMate 3 LVAD—with its Full MagLev Technology—takes an established innovation and improves upon it in meaningful ways to help people with advanced heart failure live fuller lives.”
The FDA approval for the HeartMate 3 system was backed by data from the MOMENTUM 3 study, which showed that patients with the HeartMate 3 LVAD had an unprecedented survival rate of 82.8% at two years. Furthermore, rates of suspected pump thrombosis (clotting of blood) remained very low at 1.1% at two years. The study also showcased the lowest-ever published stroke rate (10 percent) for a continuous-flow LVAD at two years.