The FDA has approved Abbott’s Full MagLev HeartMate 3 Left Ventricular Assist System (LVAD), a new option for advanced heart failure patients in need of short-term hemodynamic support (bridge-to-transplant or bridge to myocardial recovery). The system provides improved blood flow in a pump that uses full magnetic levitation to reduce trauma to blood passing through it.
More than 5.7 million people in the U.S. suffer from heart failure, and approximately 915,000 new patients are diagnosed with the disease each year. For advanced heart failure patients who can no longer rely on earlier-stage treatment options, an LVAD can help the weakened heart pump blood through the body and provide crucial support as patients await further treatment, including heart transplants.
U.S. approval of the HeartMate 3 system was supported by the MOMENTUM 3 clinical study. In that study, patients who received a HeartMate 3 system had a significant improvement in their heart failure status, an 83% increase in their walk distance, and a 68% improvement in quality of life at six months. Patients receiving HeartMate 3 also had an 86% survival rate with freedom from disabling stroke and reoperation to replace the pump at six months. The system had no instances of suspected or established blood clotting within the pump at six months.
The MOMENTUM 3 study includes 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 six months and continue to be followed for a long-term endpoint of two years.
In developing the HeartMate 3, Abbott reduced the system's size while reimagining how blood passes through an LVAD.
In traditional LVAD pumps, plasma, white blood cells, and oxygen-rich red blood cells passing through a mechanical pump can be damaged by the system's bearings. The HeartMate 3 system uses fully magnetically levitated flow technology, which allows the device's rotor to be "suspended" by magnetic forces—rather than bearings—with the goal of being able to more gently pass the blood cells through the pump. The magnets keep the rotor in place by calibrating tens of thousands of times per second to ensure it stays suspended and centered within the pump, no matter the speed settings used by a physician. This ensures the pump is performing effectively while continuing to deliver the best patient therapy possible.
The HeartMate 3 system also uses the industry's widest pump pathway, Abbott says, designed so the blood cells are not damaged when passing through. And the system also relies on a built-in "pulse" programmed to help ensure the blood continues to move through without becoming static, therefore reducing the risk of blood clot formation.
The HeartMate 3 system includes the LVAD pump as well as the rest of the components that are crucial to making this technology work—an external, wearable controller, driveline, and battery system that powers the pump.
Source: Abbott; August 28, 2017.