FDA Approves Abbott Vascular's HeartMate 3 for Advanced Heart Failure Patients

October 19, 2018—Abbott Vascular announced that the HeartMate 3 left ventricular assist device (LVAD) has received FDA approval as a destination therapy for people living with advanced heart failure. With the approval, physicians can now offer the HeartMate 3 system to patients not eligible for a transplant who will live with their device for the rest of their lives.

In the company's announcement, Nir Uriel, MD, commented, "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. 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." Dr. Uriel is Director of Heart Failure, Transplant, and Mechanical Circulatory Support at the University of Chicago Medicine in Chicago, Illinois.

Abbott's HeartMate 3 system provides a reduced size for an LVAD system that reimagines how blood passes through a heart pump. The HeartMate 3 pump utilizes the company's Full MagLev technology for fully magnetically-levitated flow, which reduces trauma to the blood passing through the pump while improving flow.

The HeartMate 3 system's FDA approval was supported by clinical data from the MOMENTUM 3, which included more than 1,000 patients with New York Heart Association class IIIB or IV heart failure. Patients were followed for a short-term endpoint of 6 months and a long-term endpoint of 2 years.

In the study, patients with the HeartMate 3 LVAD had a survival rate of 82.8% at 2 years. Furthermore, rates of suspected pump thrombosis remained very low at 1.2% at 2 years. The study also demonstrated a 10% stroke rate at 2 years.

The 2-year follow-up data from the MOMENTUM 3 clinical trial were presented by Mandeep R. Mehra, MD, in a late-breaking trial session at the American College of Cardiology's 67th annual scientific session held March 10–12, 2018, in Orlando, Florida. The study findings were simultaneously published by Dr. Mehra et al online in The New England Journal of Medicine (2018;378:1386–1395).

The HeartMate 3 system includes the LVAD pump as well as other components that help power and monitor the technology, including an external, wearable controller and battery system. The HeartMate 3 system received CE Mark approval in Europe for both short-term and long-term support in October 2015 and FDA approval for short-term support in August 2017.